INSTRUCTIONS FOR USE

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Dentatus Atlas® Implant System, approved for long-term use, provide stable anchor supportand stabilization for problematic dentures. The Atlas Tuf-Link® lined overdentures createcushioned chewing impact and firm retention without the need of the restrictive metalcoping O-ring technologies.

Dentatus denture instruments are designed for uniform depth reduction and for creatingan inverted seam line encasement that holds the reline firmly in place without adhesives.The single short chairside procedure of installing the resilient liner prevents stress and tissue abrasions especially over uneven and bulbous ridges without follow-up tissueadjustment appointments.

The Atlas Dome Keeper with Tuf-Link can provide comfort and retention for full denturesand partial removables without the need of claps or bar-clip retentive devices.

The patented Dentatus signature Monorail, Anew, and Atlas Narrow-Body Implant tech-nologies offer dentistry economic solutions with chairside crafted immediate restorationsfor patients with limited bone, narrow spaces and where larger conventional implant fixturescan not be used.

The Dentatus Narrow-Body Implant surgical restorative protocols were developed in conjunctionwith the Department of Implant Dentistry, New York University College of Dentistry.

Dentatus AB, founded in 1930, continues to maintain its leadership position with distinctiveproducts used worldwide in technical and restorative procedures.

Bernard Weissman— President

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CAUTIONS AND NOTES

Atlas sterilized implants, attached with themanual carrier drivers, are designed fordirect, safe, initial implant installation.Accessories, including drills and reamers,are delivered factory clean and afterremoving their wrappings, they shall besterilized in compliance with surgical protocols before use.

All devices employed in the clinical proce-dures shall be sterilized prior to use withautoclave steam sterilization. The followingparameters have been validated in accor-dance with FDA recognized standardANSI/ISO 11134:1993, to provide aSterility Assurance of 10-6. Temp: 132°C,Pressure: 30psi, Time: 8 minutes.However, the health facility should validateits own autoclave steam sterilization machinein accordance with a recognized standard(in the USA: FDA approved standard).

The CePo™ Pilot Drills and reamers shouldbe used with copious sterile water to preventoverheating damage and possible bonenecrosis. When creating osteotomies inmandibular D-1 and D-2 hard bone, onlysharp drills and reamers should be

used. As a safety precaution, used dull drillsshould be discarded immediately.

Extreme care should be observed to preventaccidental swallowing or aspiration ofimplants or other related small accessorycomponents used in these procedures.When possible, tools should be attachedwith a fine cord to the patient’s garment.

Special consideration should be given forthe use of Atlas Implants for upper dentures.The softer maxilla bone and anatomicalrestrictions must be carefully consideredbefore their use.

Caution - Federal law restricts the sale ofthis device to a licensed physician or dentist.The printed guidelines, including Cautionsand Notes, are to be regarded as additionsto accepted clinical procedures and surgicalprotocols.

Dentatus Narrow-Bodied Ti alloy implantsare FDA designated for long-term use andfor any length of time as decided by thehealthcare provider.

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ATLAS CLINICAL PROCEDURES

To determine the position and angle forimplant installation, appropriate CT (CAT)scans, X-rays and measurements should beused to establish ideal implant placement.Right-angle calipers can be used toobserve the width of bone with specialattention to the irregularities in bucco-lingual jaw concavities.

The level of bone may be estimated byusing a ruler to establish the total ridgeheight by placing the ruler under the chinup to the height of the ridge. An approxi-mate volume of 6-8 mm soft tissue underthe chin and over the ridge is deducted,and the remaining solid bone measure-ment is used as a guide to select anappropriate length implant.

A.

The locations for the implants should beindicated with a sterile marking pen on themucosa. 4 Atlas Implants should be placedanterior to the mental foramina and sepa-rated equidistantly for a balanced, cross-archstabilization and retention.

The Dentatus CePo Pilot 1.3 Drill is initiallyused to puncture the tissue (without rota-tion) indenting the bone for precise locationof the osteotomies. The drills, operated at1500-2000 RPM with copious waterspray, are angled for implant installation inbone. The osteotomies are drilled to the

depth for the implant platform to seat inthe mucosa.

The CePo Drill laser marks are designedfor implant installation performed withsurgical flap procedures of exposed bone.In flapless procedures, the osteotomiesare made 4-5 mm deeper to compensatefor the variable levels of mucosa and toprevent bottoming-out space for theimplants.

B.

As a safety measure, visual observationcan be made by lining up the drill againstthe selected implant indicated with a markeror placing a silicone sleeve on the drill shankup to the level with the implant platform.

Note: Local anesthetic infiltration is con-sidered adequate for these procedures.

All osteotomies are first made with the 1.3CePo Pilot Drill. For placing the wider 2.2or 2.4 implants, the openings are enlargedwith the 2.2 or 2.4 marked drills or reamersin a straight up and down motion to thepre-drilled depth.

Note: Aligning the drill position for theosteotomies, the thumb and index fingermay be placed on either side of the ridge tofacilitate tactile feedback when the drill isin motion in close proximity to the mucosa.

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C.Implant Installation

The sterile manual carrier driver attachedto the sterilized implant is used to safelyinstall the implant by a few threads.

The carrier driver is removed and theinstallation may be continued with the R/AHpc driver (in the range of 50 RPM) or withthe Extended Power Ratchet Wrench(short of the platform contacting themucosal tissue). The installation is com-pleted with the winged manual driver thatprovides tactile feedback of its propercomplete installation.

When excessive resistance is perceived,the implant is removed and the osteotomyis made slightly deeper. This will preventhigh stress bottoming-out resistance, andprevent possible damage to mandibularhard bone.

D.Clinical Prosthetic Procedures

Caution:

When an existing denture cannot be locatedspatially on the ridge aligned with theopposing teeth, the denture should be firstrelined with quick auto-cure resin beforeinitiating the retrofitting procedure.

A marking pen is used to mark the outlinein the denture for a seam line position that

should be located 2-3 mm below theflange extensions. The marking is extendedup to the retromolar pads in a curved formfor seamless liner adaptation.

1. The (#1) half-sphere cutting instrumentis used to create an inverted seam lineencasement for retention of the linerwithout adhesives. The instrumentshank is leaned against the flange as abracing guide for creating a depth-con-trolled continuous seam line.

2. The (#2) spherical grooved diamondplated instrument is used to createdepth mark tracks in the denture with-out causing damage to the preparedseam line for reducing the base for auniform liner.

3. The (#3) spherical cutting instrument isused to reduce the base to the depthmarked levels and to create a smoothsurface.

4. The marking caps, placed on the AtlasImplants are used to mark their posi-tion in the denture. The caps are paint-ed with any safe vegetable-based col-orant or marker and the denture isfirmly pressed down to transfer themarked positions for the DomeKeepers.

5. The #3 round denture instrument isused to indent the marked spacesallowing the denture to seat passively

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in place. To prevent excessive denturereduction, the # 3 instrument should besunk down 2/3 of its spherical depth.

Note: A confirming check can be performed by applying markingsdirectly to the Dome Keeper heads for afinal touch up and rounding off all sharpprojections to prevent incipient tears inthe silicone liner.

E.Silicone Relining Procedures

Note: The patient's mouth, tongue anddenture are thoroughly rinsed to removefine particles that may become embeddedin the liner. Preparing for the quick relineprocedure, the patient should be cautionedthat they will need to gently press the den-ture in place in contact with their opposingteeth and keep firmly in place for 4-6 min-utes without tongue or jaw movements.

1. The Tuf-Link 50 ml dispenser with anauto-mixing tip is bled before injectingthe silicone into the denture base, theflow is guided into the seam line.Sufficient silicone should be used tocreate pressure required for a dense,porous-free liner.

2. The denture is inserted from the poste-rior direction and guided forward withpulsating side motions. The patient isguided to contact the opposing teethand hold still in place. The procedure

must be carried out expeditiously, asthe silicone begins to set during theearly stages of polymerization.

3. When polymerized, the denture isremoved and the liner is gently liftedout of the denture base with a pointedinstrument at one of the distal extensions.

4. The excess liner is cut away along thewell delineated seam line with long-nosed fine scissors.

5. To reinsert the liner, it is first located atone extreme end of the denture andguided into place with light finger pres-sure. A smooth flat instrument may beused to guide the reline into the seamline which will prevent fine food particleaccumulation.

Atlas Tuf-Link self-aligning dentures toler-ate substantial implant angulations. Thedenture, removed without implant stressor tissue abrasions, rarely requires follow-up tissue adjustment appointments.Depending on variable conditions, the lin-ers should remain resilient for 12 – 18months. Although they are quicklyreplaceable, a spare liner can be made forpatients to keep it in a water filled contain-er for emergency use.

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POST-OP CHECKLIST

a. Muscle impinging areas, the frequentcause of denture dislocation in func-tional and parafunctional movementsshould be eliminated.

b. Occlusal contacts and tripping interfer-ences should be corrected.

c. The patient should immediately reportany irregularities or discomfort.

PATIENT HOME-CARE INSTRUCTIONS

Patients can immediately ingest food;however, they should observe a 36 hoursoft diet regimen.

a. Patient should have a light diet withouthard or chewy foods for 24 hours

b. Patient should not remove their dentureat night for the first two weeksfollowingAtlas placement. This will prevent anyedema initiated by the surgical place-ment from forcing the soft tissue up,possibly interfering with the reseatingof the denture on the implants. After thetwo week period patients may sleepwith or without their Dentures.

c. Patient should remove denture brieflyeach day for oral hygiene. Instruct themto use a soft nylon bristle toothbrush withtoothpaste or water to scrub the denture.Do not have patient attempt to remove

the silicone liner for at least 3 days. Afterthis initial period, patients with good dexterity may remove the liner [with a toothpick] and clean it gently in the samemanner as the denture. After the initialhealing period, dentures may be soakedfor 30 minutes each day in a denturecleaning solution. [Note: instruct patientsnot to clean their dentures or siliconerelines over an open sink drain.] Instructpatients how to clean the head, collarand platform of the four Atlas implants.

d. Patient may use a pain-relieving medica-ment to alleviate any discomfort.

e. Patient should be instructed to call the officeif any serious pain or other symptoms arise.

RETROFITTING MAXILLA IMPLANT-SUPPORTED OVERDENTURES ANDREMOVABLE PARTIALS

Retrofitting technical procedures forimplant-supported dentures are substan-tially the same as described in the Atlasmanual for mandible overdentures.

The softer, porous maxillary bone may not beable to withstand the functional forces withouta splinted bar interconnecting 6-8 implants.The Dentatus Anew Implants with compo-nents design for fixed restoration can be usedto create a resin-metal splint. Retrofitting thedenture with the Tuf-Link silicone liner pro-vides cushioned, comfortable, and a secureretention with a modified palatal form.

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Careful consideration should be given tothe maxilla and anatomical limitations andbone by using 6-8 implants with shallowosteotomies to half the depth made in hardbone. The self threading Anew Implantsinstalled with the manual driver will createtheir own condensed thread form in the bone.

The Anew System, designed for recon-structive procedures are used for replac-ing single teeth, multi-unit restorationsand full arch screw-retained fixed bridges.The minimally invasive less demandingsurgical and clinical procedures areaccessible and more affordable to themuch larger range of patients’ needs.

The Anew Implant illustrated technicalmanual for replacing missing single teeth,multi-unit and full-arch restorations areavailable upon request.

TUF-LINK® SILICONE MATERIAL FORUSE IN THE GENERAL PRACTICE.

The Dentatus Tuf-Link resilient liner thatmaintain stable forms over lengthy periodsof time may be used to reline upper den-tures, partial removables, sinus lift andhard and soft reconstructive procedures.The liner can also be used to line recordingbase forms to establish accurate occlusal,vertical and spatial relations preventingdamage to master casts.

The Tuf-Link 50 ml dispenser with automixing tips is convenient for large volume

relines. The Tuf-Link-Patch small 10 mldispenser, manually spatulated, is designedfor small relines and to quickly relieve tissueabrasions. Two small indents made with(#1) and (#2) round burs spaced 3 – 4 mmapart will securely retain the patch inplace. The space may be permanently re-filled with hard resin after healing.

Other applications are in surgical proce-dures where tissue sites need to be safelyprotected over lengthy periods of time.Tuf-Link silicone material is dense andporous-free, preventing food impactionand bacterial accumulation.

ATLAS MARKETING PROGRAM

The Atlas Denture Comfort program withprint and media materials can help youjump-start your implant practice to thevery large number of patients that sufferwith inadequate restorations. The marketingprogram is based around the consumerwebsite www.denturecomfort.com featuringa Dentist locator by zip code. The programincludes marketing tools such as patientbrochures, posters, post-cards, pressreleases and much more. Call Dentatus at+1 800-323-3136 to see how you cantake advantage of these opportunities,many of them free of charge.

You can also reach us through e-mail atdentatus@dentatus.com or see the fullline of Dentatus distinctive products on theweb at www.dentatus.com.

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Item Cat# Description

1 MR-1041 1.8mm Profile Drill-Long2 MR-1042 1.8mm Profile Drill-Short3 MR-1045 2.2mm Profile Drill-Short4 MR-1046 2.4mm Profile Drill-Short5 AR-91 1.8mm Reamer6 AR-92 2.2mm Reamer7 AR-93 2.4mm Reamer8 AR-8 Manual Driver9 AR-110 R/A Hpc. Drive

Atlas Intro Accessory KitAK

Contains: 1x CePo Profile Drill-Short, 1x 2.2mm & 1x 2.4mmSizing Reamer, 1x Set of 3Denture Forming Instruments,1x Manual Driver, 1x R/A Hpc.Driver, 12x Marking Caps & 1xSterifix Cassette

Item Cat# Description

10 AR-9 3 Denture Forming Instruments11 AR-15 Brass Analogs12 AR-40 Marking Caps13 TK-10 Tuf-Link 10ml Silicone Dispensers14 TK-50 Tuf-Link 50ml Silicone Cartridge15 TK-G Tuf-Link Dispenser Gun16 TK-T Tuf-Link Auto-Mixing Tips17 MPD Power Driver18 MPD-AT Atlas MPD Bit

1.8 2.2 2.4AT-18L-R AT-22L-R AT-24L-R

AT-18M-R AT-22M-R AT-24M-RAT-18S-R AT-22S-R AT-24S-RLE

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