Sales_CDA Anaheim_Beautifil II NEW Enamel_Gingiva Colors

Beautifil II Gingiva & Enamel —fluoride-releasing, bioactive, Giomer composites

in pink and white shades

Reasoning behind the creation of gingiva- & enamel-colored composites

• Promotes minimally-invasive dentistry eg. effective substitute for ceramic veneers

• Creates aesthetic solutions without substantial financial investment

• Follows the philosophy of porcelain/ceramic side of dentistry

• Aging population: desire to retain teeth & reestablish youthfulness • Direct restorative without the indirect lab work• Artistic repair of partial dentures (with CeraResin Bond adhesive and Metal/Liquid primer) • Ability to correct wedge-shaped defects, mask exposed implant abutments, and more

• Offers ability to treat ethnically-diverse population

U.S. Market Overview: gingiva-colored composites

Manufacturer

[Grams] or [mL]

converted to Grams

Retail Price

Price per Gram

ShofuBeautifil II, 2.5 g syringe

universal composite

Gingiva Refill

Syringe 2.50 $49.95 $19.98

Cosmedent Renamel Gingafillmicrofill

compositeGingiva

Refill Syringe

3.50 $112.45 $32.13

ANAXDENTAnaxagum Paste Composite

fiber reinforced composite

Gingiva Refill

Syringe 4.00 $77.00 $19.25

ANAXDENT Anaxagum Flowfiber

reinforced composite

Gingiva Refill

Syringe 3.00 $50.00 $16.67

ANAXDENTAnaxagum Paint (Stain)


Gingiva Refill

Syringe 3.00 $72.00 $24.00

ANAXDENT Anaxagum Opaquerfiber


Gingiva Refill

Syringe 3.00 $55.00 $18.33

GC America Gradia Direct Xuniversal

compositeGingiva

Refill Syringe

5.00 $119.99 $24.00

Kerr Premiseuniversal

compositeGingiva

Refill Syringe

4.00 $124.99 $31.25

Kerr Herculite XRVuniversal

compositeGingiva

Refill Syringe

5.00 $130.99 $26.20

SDI Wavenanohybrid

flowableGingiva

Refill Syringe

1.00 $21.79 $21.79

VOCO Amaris universal

compositeGingiva

Refill Syringe

4.00 $111.99 $28.00

Gingiva-colored composites | Syringes -- Refills and Kits Source: 2016 Henry Schein Catalogue

U.S. Market Overview: enamel-colored composites

Manufacturer

[Grams] or [mL]

converted to Grams

Retail Price

Price per Gram

ShofuBeautifil II, 2.5 g syringe

universal composite

EnamelRefill

Syringe 2.50 $37.50 $15.00

Dentsply Caulk

TPH Spectra HV (high viscosity flowable)

universal composite

Dentin & EnamelRefill

Syringe 3.00 $55.49 $18.50

Dentsply Caulk

Esthet-X HDuniversal

compositeDentin & Enamel

Refill Syringe

3.00 $81.99 $27.33

GC America G-aenial Sculpt universal


Refill Syringe

3.60 $110.99 $30.83

GC America Gradia Direct Xuniversal


Refill Syringe

5.00 $119.99 $24.00

Ivoclar Tetric EvoCeramuniversal


Refill Syringe

3.00 $71.49 $23.83

Kerr Herculite Ultrauniversal


Refill Syringe

4.00 $121.99 $30.50

Kerr Herculite XRVmicrohybrid composite


Syringe 5.00 $124.99 $25.00

Kurary Clearfil Majesty ES-2 Premium

universal composite


Syringe 3.60 $90.99 $25.28

Tokuyama Estelite Omegauniversal,

supra-nano filled


Syringe 4.00 $99.99 $25.00

Ultradent Vit-l-escencemicrohybrid composite


Syringe 2.50 $54.49 $21.80

VOCO Amarisuniversal

compositeDentin & Enamel Syringe 4.00 $97.99 $24.50

Enamel-colored composites | Syringes -- Refills and Kits Source: 2016 Henry Schein Catalogue

Manufacturer

[Grams] or [mL]

converted to Grams

Retail Price

Price per Gram

ShofuBeautifil II Gingiva "PINK" Kit

universal composite

6-syringe kit, each 2.5-gram, incl. of 5 gingiva colors + 1 Beautifil Flow F02, gingiva,

BONUS

Syringe Kit 14.50 $249.00 $17.17

ShofuBeautifil II Gingiva & Enamel "PINK & WHITE" Kit

universal composite

10-syringe kit, each 2.5-gram, incl. of 9 gingiva colors + 1 Beautifil Flow F02, gingiva,

BONUS

Syringe Kit 24.50 $399.00 $16.29

ANAXDENT ANAXGUM KIT Sfiber


4-syringe kit incl. of 2x4g paste, 2x3g modifier paint

(stain)Syringe Kit 14.00 $265.00 $18.93

ANAXDENT ANAXGUM KIT XLfiber


10-syringe kit incl. of 2x3g opaquers, 5x4g paste, 4x3g

modifier paint (stain)Syringe Kit 38.00 $695.00 $18.29

ANAXDENTANAXGUM KIT XXL (FULL SYSTEM)


16-syringe kit incl. of 2x3g opaquers, 5x4g paste, 4x3g flow, 5x3g modifier paint

(stain)

Syringe Kit 53.00 $899.00 $16.96

Cosmedent

Renamel Gingafill Syringe Kit

microfill composite

5-syringe kit, each 3.5-gram Syringe Kit 17.50 $533.95 $30.51

TokuyamaEstelite Omega Basic Kit

universal, supra-nano

filled

6-syringe kit, each 4g, incl. ENAMEL & DENTIN shades

Syringe Kit 24.00 $524.00 $21.83

TokuyamaEstelite Omega Syringe DeLuxe Kit

universal, supra-nano

filled

11-syringe kit, each 4g, incl. of ENAMEL & DENTIN shades

Syringe Kit 44.00 $840.99 $19.11

VOCO Amaris Gingiva Syringe Kit

universal composite

4-syringe kit, incl. of 3x1.2g opaquers in white, light, dark,

1x4g basic color "nature"Syringe Kit 7.60 $269.99 $35.53

Gingiva-colored composites | Syringes -- Refills and Kits Source: 2016 Henry Schein Catalogue

U.S. Market Overview: gingiva-colored technique kits

Beautifil II: Nanohybrid Giomer composite with fluoride release & recharge properties

• Highly filled, bioactive Giomer composite

• with excellent flexural and compressive strength

• Optimal consistency without slumping, bubbling, or oozing

• Maintains excellent color stability before and after curing

• Creates restorations with optical characteristics of natural teeth

• Incorporates Giomer fillers proven to:• Sustainably release and recharge • Inhibit plaque growth • Acid neutralization properties

• Validated in 8-year and 13-year recall studies

• Filler Load: 83 wt%

• Compressive Strength: 325 MPa

• Flexural Strength: 130 MPa

• Flexural Modulus: 14 GPa

• Vickers Hardness: 62 Hv

• Wear Resistance: 0.52 wt%

• Radiopacity: 3.4 Al:mm

Beautifil II Gingiva & Enamel: Indications

Beautifil II Enamel• Chameleon-like optical characteristics

allow to create polychromatic restorations with morphology and aesthetics of natural teeth

• Provides clinicians with cost-effective alternative to ceramic veneers

• Shades can be layered and blended together to produce highly aesthetic results

Beautifil II Gingiva • Intended for the cervical area:

• reestablishment of gingival symmetry • aesthetic correction of gingival

recession• wedge-shaped defects • exposed cervical areas • splinting • re-balancing of pink and white

aesthetics

• Enables to artistically camouflage exposed crown and bridge margins, implant abutments

• Allows to characterize removable full or partial dentures (with CeraResin Bond adhesive and Metal/Liquid primer)

• Shades can be layered and coalesced to address patients’ broad clinical needs

Beautifil II Enamel available in 4 enamel shades

HVT T LVT AM

High-Value Translucent

Translucent Low-Value Translucent

Amber

Beautifil II Gingiva & Enamel Shade Guides

Beautifil II Gingiva available in 5 gingiva shades

Light Pink Dark Pink Orange Brown Violet

Beautifil II Gingiva: Physical & Mechanical Properties

Product name AMARIS Gingiva anaxGUM

Manufacturer VOCO anaxDENTShade G-Dark Pink G-Light Pink G-Brown G-Orange G-Violet Nature Dark Pink

Tyep of container Screw rod Screw rodFlexural Strength (MPa) 110 116 115 122 119 106 99Flexural modulus (GPa) 9.8 9.4 9.5 9.6 9.3 6.2 7.1

Vickers hardness (Hv 0.1)： 44 48 45 44 48 35 45Depth of cure (mm) 1.5 2.1 1.6 1.6 2.1 2.4 2.1Working time (sec) 180 180 180 180 180 180 90Radiopacity (Al:mm) 2.5 2.5 2.5 2.5 2.5 0 1.4

Contrast ratio 0.70 0.72 0.73 0.71 0.76 0.40 0.52Transition of contrast ratio ⊿0.00 ⊿0.01 ⊿0.01 ⊿0.01 ⊿0.01 ⊿-0.24 ⊿-0.22

Before → After 0.71 → 0.71 0.73 → 0.74 0.75 → 0.76 0.72 → 0.73 0.74 → 0.75 0.63 → 0.39 0.75 → 0.53Light diffusion ability ○ ○ ○ ○ ○ × ○

Ion release & recharge ability ○ ○ ○ ○ ○ × ×Acid neutralization ○ ○ ○ ○ ○ × ×

One-Push rod

BEAUTIFIL Ⅱ Gingiva

SHOFU

Beautifil II Enamel: Physical & Mechanical Properties

Product name BEAUTIFIL ⅡManufacturer

Shade HVT T LVT AM A3EnamelShadeA3E

Body ShadeA3B

Enamel shadeA3

Dentin ShadeA3

Enamel shadeE3

Dentin ShadeA3

Tyep of container Screw rod/ tipFlexural Strength (MPa) 126 119 113 119 130 133 135 117 118 97 92Flexural modulus (GPa) 9.6 9.2 9.0 9.2 14.0 12.0 12.2 8.8 9.3 5.2 5.4

Vickers hardness (Hv 0.1)： 51 50 49 50 62 82 78 50 36 31 29Depth of cure (mm) 4.4 4.1 3.7 2.5 2.5 3.2 2.5 2.6 1.8 3.7 2.5Working time (sec) 100 90 110 170 70 100 90 100 110 180< 180<

Radiopacity (Al:mm) 2.5 2.5 2.5 2.5 3.4 2.3 2.3 1.8 3.3 <1.0 <1.0Transition of contrast ratio ⊿0.01 ⊿0.00 ⊿0.00 ⊿0.02 ⊿0.00 Δ0.06 Δ0.03 Δ0.12 Δ0.07 Δ0.13 Δ0.09

Before → After 0.43 → 0.42 0.42 → 0.42 0.43 → 0.43 0.50 → 0.52 0.580→0.580 0.56 → 0.50 0.63 → 0.60 0.60 → 0.48 0.76 → 0.69 0.58 → 0.45 0.61 → 0.52Polishability1) 51 50 51 52 37 41 - 53 - 28 -

Abrasion wear with opposing teeth mm（） 6.3 - - - 15.5 11.0 - 6.6 - 5.7 -Light diffusion ability × × × × ○ × × × × × ×

Ion release & recharge ability ○ ○ ○ ○ ○ × × × × × ×Acid neutralization ○ ○ ○ ○ ○ × × × × × ×

1)After polishing the specimen of CR(φ15, t=2mm) with waterproof abrasive paper, polish it with Compo-master #13S in loaded on 100gt in 10000rpm for 15sec and 30sec. Then measuring the polish the glossiness 60° .（）

Ivoclar vivadent GC

One-Push rod Screw rod / tip Screw rod / tip Screw rod / tip

BEAUTIFIL Ⅱ Enamel Filtek Supreme Ultra IPS Empress Direct GRADIA DIRECT SHOFU M３

Beautifil II Gingiva & Enamel: new, ergonomic syringe

Ergonomic “one-push” syringe allows for more efficient composite handling and application

One-push syringe vs. traditional syringe

Beautifil Restorative Materials: Color-compatibility & Blendability

Color-compatible and blendable across the entire Beautifil line of restorative materials

• Beautifil Flow – injectable flowable • Beautifil Flow Plus – injectable nanohybrid composite • Beautifil-Bulk Flowable – injectable bulk-fill composite • Beautifil-Bulk Restorative – packable bulk-fill composite

Beautifil II Gingiva & Enamel with Giomer Technology

What is a Giomer

• Giomer is a collective term for bioactive materials (nano-hybrid resin composites—packable, flowable, bulks—cements, bonding agents, sealant, and light-cure varnish) which contain Shofu’s proprietary S-PRG fillers.

• Bioactive/biointeractive: material forms an apatite-like layer on its surface1A; materials interact with or affect the biological tissue1B

• Biocompatible: not harmful to living tissue

• Giomers combine biological effectiveness of glass ionomer (fluoride release/recharge and other beneficial ions) with outstanding physical and mechanical properties, and durable and predictable aesthetics.

1AS.R. Jefferies, MS, DDS, PhD, Bioactive Dental Materials, Inside Dentistry. Feb. 20161BGoldstep F., DDS, Proactive intervention. Taking control with remineralization and bioactive materials, Compendium, June 2012;33;6:3-11

The Giomer Concept2

2Shofu, Scientific Evidence, Giomer PRG Technology, 2014:1

The Giomer Concept continued

• Giomers are based on S-PRG Technology in which surface pre-reacted glass-ionomer is used as a filler.

• S-PRG fillers are obtained by reacting multifunctional fluoro-boro-alumino-silicate glass filler with polyacrylic acid, in the presence of water.3

• The resultant trilaminar structure forms stable glass-ionomer that allows for release and recharge of beneficial ions while protecting the glass core to improve the material’s long-term durability.

3Shofu, Scientific Evidence, Giomer PRG Technology. 2014:1

Composition of Giomer filler

Functions of Giomer layers

Function of the surface-modified layer

• Protects the filler from water sorption and degradation, giving Giomer materials long-term durability

Functions of the glass-ionomer phase

• Releases and recharges fluoride, F-, and other beneficial ions, Sr2+, AI3+, SiO3

2-, BO33-, Na+

• Acid neutralization• Anti-plaque function• Bactericidal properties

F- : Fluoride ion− Improves acid resistance by forming fluoro-apatite− Displays antibacterial effects− Exhibits caries-preventive properties

Sr2+ : Strontium ion− Improves acid resistance by forming strontium-apatite− Inhibits dentinal hypersensitivity− Acts on hydroxyl-apatite to convert it into fluoro-apatite − Promotes bone formation

Biological effects of beneficial ions

AI3+ : Aluminium ion− Improves radiopacity− Inhibits dentinal hypersensitivity

SiO32- : Silicate ion

− Induces remineralization − Promotes bone formation

BO33- : Boron ion

− Exhibits bactericidal properties

Na+ : Natrium (Sodium) ion − Improves radiopacity

Biological effects of beneficial ions continued

Clinical benefits of Giomer materials

• Release and recharge fluoride4,6,7 and other beneficial ions11,15

• Form acid-resistant layer4 which can transpose to adjacent teeth13,16

• Neutralize acids to establish stable pH in the oral environment14

• Inhibit biofilm formation and disrupt mature biofilm4,5

• Exhibit anti-plaque properties by reducing plaque formation & bacterial adherence8,9,10,14

• Possess antibacterial functions10,11 • Exhibit caries-preventive properties12

• Have the potential for secondary caries prevention7,9,10,14,17

4Shofu, Scientific Evidence, Effects of surface pre-reacted glass ionomer fillers on mineral induction by phosphoroprotein. 2011:45ibid, Effects of S-PRG eluate on oral biofilm and oral malodor. 2014:5 6ibid, Fluoride release and recharge capabilities of orthodontic resin containing S-PRG filler. 2013:67Han L, Cv E, Li M., et al. Effect of fluoride mouth rinse on fluoride releasing and recharging from aesthetic dental materials, 2002. 21: 285-295 8Shofu, Study on the file layer produced from S-PRG filler. 2004:89 ibid, The anti-plaque effect of fluoride releasing light-cured composite resin restorative material. 2002:9 10ibid, Antibacterial activity of composite resin with glass-ionomer filler particles. 2010:10 11ibid, Antibacterial activity of S-PRG filler. 2003:18 12ibid, Caries-preventive effect of fissure sealant containing surface reaction-type pre-reacted glass ionomer filler and bonded by self-etching primer. 2012:20 13ibid, Acid resistance induced by a new orthodontic bonding system in vitro. 2008:21 14Gordan V.V., et al. A clinical evaluation of a self-etching primer and a Giomer restorative material: results at 8 years. JAM Dent. Assoc. 2007;138:621-627 15Kamijo K., Mukai Y., et al. Fluoride release and recharge characteristics of denture-base resins containing surface pre-reacted glass-ionomer filler. Dent. Material J. 2009;28:227-23316Han L., Okamoto A., et al. Evaluation of a new fluoride-releasing one-step adhesive. Dent. Material J. 2006;25:509-515

Release/recharge of fluoride

and other beneficial ions

Less plaque Full grown plaque

Competitive material(without S-PRG fillers)

Beautifil II (with S-PRG fillers)

SEM images of plaque on restorative surface after 24 hours without brushing

Anti-plaque properties: reducing plaque formation & bacterial adherence

Clinical benefits of Giomer materials continued

• Demonstrate excellent physical and mechanical properties for durable and predictable aesthetics14,18,19,21

• Excellent optical properties: radiopacity greater than enamel20

• Superb polishability and luster20

• Exhibit optimal handling which helps improve marginal adaptation and contouring of restorations, without slumping or sticking17

• Available in variety of shades to provide life-like aesthetics

17Milnar F., Direct composite and finishing/polishing systems for esthetic anterior restorations. Inside Dentistry, Oct. 2014:58-6218Milnar F., Conservatively recreating a smile. Dentistry Today, Feb. 2016 19Gordan V.V., et al. A clinical evaluation a Giomer restorative system: 13-year recall. JAM Dent. Assoc. 2014;145;10:1036-104320Yapp R.A, MS, Cowen M, BS, Powers J.M., PhD, The Dental Advisor, Apr. 2015;32;3: 721Abdel-karim U.M., El-Eraky M., Etman W.M., 3-year clinical evaluation of two nano-hybrid giomer restorative composites. 2014:214-222

Validated in 8- and 13-year clinical studies

• 8-year study published in JADA, 2007

• 16 of 26 Class I, and 25 of 35 Class II restorations were observed

• No failures• No secondary caries• Maintained aesthetics

• No post-op sensitivity

• 13-year study presented at IADR, 2013 poster session

• 19 of 26 Class I, and 22 of 35 restorations were observed

• 66% retention rate (27 of 41)

• 3.27% secondary caries rate (2 of 61) restorations

13-year StudyPhotos

Overall positive results and low secondary caries attributed to the Giomer Technology

Beautifil II Gingiva & Enamel: Clinical cases by Frank J. Milnar, DDS, AAACD

Beautifil II Gingiva: Before Beautifil II Gingiva: After

Beautifil II Gingiva: Before Beautifil II Gingiva: After

Beautifil II Enamel: Before Beautifil II Enamel: After

Beautifil II Gingiva & Enamel: available in single syringes and technique kits

PN Beautifil II Gingiva. SRP: $49.95/syringe PN Beautifil II Enamel. SRP: $37.50/syringe Y2256 Light Pink, G-LP, 2.5g Y2250 Translucent, T, 2.5g Y2257 Dark Pink, G-DP, 2.5g Y2251 High-Value Translucent, HVT, 2.5g Y2258 Violet, G-V, 2.5g Y2252 Low-Value Translucent, LVT, 2.5g Y2259 Brown, G-Br, 2.5g Y2253 Amber, AM, 2.5g Y2260 Orange, G-Or, 2.5g

Beautifil II Gingiva & Enamel: Technique Kits

PN GMK1—Beautifil II Gingiva "PINK" Kit content

PN GMK3—Beautifil II Gingiva & Enamel Kit content

Beautifil II, Gingiva, Light Pink, G-LP, 2.5g Beautifil II, Gingiva, Light Pink, G-LP, 2.5g

Beautifil II, Gingiva, Dark Pink, G-DP, 2.5g Beautifil II, Gingiva, Dark Pink, G-DP, 2.5g Beautifil II, Gingiva, Violet, G-V, 2.5g Beautifil II, Gingiva, Violet, G-V, 2.5g Beautifil II, Gingiva, Brown, G-Br, 2.5g Beautifil II, Gingiva, Brown, G-Br, 2.5g

Beautifil II, Gingiva, Orange, G-Or, 2.5g Beautifil II, Gingiva, Orange, G-Or, 2.5g

Beautifil Flow F02, Gingiva, 2.0g Beautifil Flow F02, Gingiva, 2.0g

Bonus Items: Beautifil Flow Plus, F00, A2, 2 x 0.21g

Beautifil II, Enamel, Translucent, T, 2.5g

Bonus Item: Beautifil Flow Plus, F03, A2, 2 x 0.21g

Beautifil II, Enamel, High-Value Translucent, HVT, 2.5g

Bonus Item: Beautifil II, A2, 2 x 0.25g Beautifil II, Enamel, Low-Value Translucent, LVT, 2.5g

Beautifil II, Enamel, Amber, AM, 2.5g



Bonus Item: BeautiBond, 10 x 0.10ml

Bonus Item: Super-Snap Singles, Mini, 10x

Documents

Sales_CDA Anaheim_Beautifil II NEW Enamel_Gingiva Colors