DirectOss®

DEVICE DESCRIPTION

DirectOss™ is a natural hyroxyapatite bone substitute sourced from protected bovine herds. This bone substitute provides a mineralized osteoconductive structure, similar to human bone, that has been cleansed using a proprietary multi-step purification process. Following placement in the bony voids or gap, DirectOss™ acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. DirectOss™ gradually resorbs and is replaced with bone during the healing process. DirectOss™ is available in granules that have been packaged in vials or syringes.

INDICATION FOR USE

DirectOss™ granules are recommended for:

• Augmentation or reconstructive treatment of alveolar ridge • Filling of periodontal defects • Filling of defects after root resection, apicocectomy, and cystectomy • Filling of extraction sockets to enhance preservation of the alveolar ridge • Elevation of maxillary sinus floor • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) • Filling of peri-implant defects in conjunction with products intended for Guided Bone

Regeneration (GBR)

Anorganic Bovine Bone Granules

INSTRUCTION FOR PREPARATION

Site Preparation

• Raise the mucoperiosteal flap and remove the inflammation of the bony defect region using curette. • Clean the site using saline or distilled water. • Content of package is STERILE by prior exposure to gamma radiation unless opened or damaged. • Read expiration date before use. Do not use if expiration date has been exceeded.

Proper Placement and Containment of the Device

• Wet and mix DirectOss™ granules with sterile saline or patient’s blood. DirectOss™ granules and sterile saline should be mixed in a volume ratio of approximately 3:1 for 15 seconds. • Do not use excess sterile saline. • Deliver DirectOss™ to the surgical site using sterile instruments. • Loosely pack DirectOss™ into voids using sterile instruments.

<Vial Type>

• Remove vial from sterilized package and dispense desired quantity of DirectOss™ into a sterile dish with aseptic technique.

• Fill a sterile dappen dish with sterile saline solution or patient’s blood.• Slightly retract the plunger on syringe and gently tap to loosen granules, the gently push plunger back into place.• Place syringe into sterile dappen dish and retract plunger to draw liquid(0.3-0.5cc) into syringe to facilitate delivery, DirectOss™ should be wetted and loosened sufficiently. • Expel excess liquid by pushing plunger slightly. When hydrated, DirectOss® is easily expelled from the syringe. Before injecting DirectOss™ , separate cap from the syringe.• Deliver directly in the surgical site with the syringe while being careful not to break DirectOss™ granules.• In case of granules jamming, put on the cap and suck the sterile saline or blood and gently tap to loosen granules.• When using syringe, be careful not to jam, drop, break or compress.

<Syringe Type>

• Do not overfill the defects. • DirectOss™ should be placed into the bone cavity well vascularized with sufficient contact. • The flap should be sutured to achieve primary closure without any tension.

Site Closure

• Cover the flap then suture the site firmly so that implantation site will not be exposed. • Double suturing is strongly recommended due to the anticipated postoperative swelling.

Patient Care Following Treatment

• Apply a surgical dressing on the surgical area for 1 to 2 weeks.

① Slightly retract the plunger on syringe and gently tap to loosen granules, then gently push plungerback into place.

② Place syringe into sterile dappen dish and retract plunger to draw liquid into syringe.

③ To facilitate delivery, DirectOss™should be wetted and loosened sufficiently.

④ Expel excess liquid by plunger slightly.

⑤ When hydrated, DirectOss™ is easily expelled from the syringe. Before injecting DirectOss™ , separate cap from the syringe.

Filter

⑥ Deliver DirectOss™directly in the site with the syringe.

surgical pushing

CONTRAINDICATIONS

Conditions representing contraindications include:

• Osteomyelitis at the surgical site or surrounding area • The patients with liver disease and/or kidney disorders • Degenerative bone disease • Metabolic diseases (diabetes, hyperparathyroidism) or systemic bone disorders • Patients with vascular diseases • Common user of steroid (High dose therapy with corticosteroids)

ADVERSE EFFECTS

Possible adverse effects include but not limited to:

• Allergy to bone graft • Hematoma • Adverse tissue reaction • Infection • Swelling at the surgical site • Flap sloughing • Bleeding • Local inflammation • Bone loss

STERILIZATION

DirectOss™ is sterilized using gamma irradiation. A ppropriate aseptic technique should be observed in all operations. The package should be inspected prior to use to ensure that the sterile barrier has not been compromised. DirectOss™ is non-pyrogenic.

PRECAUTIONS

• Dentist should instruct patients not to apply pressure to the surgical site during a bone healing process. • Dentist should inspect and evaluate patients for any allergic response due to the implant. • A recommended 6 months healing time should be observed before implant placement. • A 6 months period should be also observed before implant loading takes place after implant placement.

• Effects on pediatric patients is not known • Effect on patients with preexisting disease conditions (metabolic bone disorder, cardiovascular disease, radiation) is not known. • Safety and effectiveness during pregnancy has not been established.

WARNINGS

• Single use only. Do not re-sterilize or reuse.

• Not intended for immediate load-bearing (advisable loading time is 6 months). • Do not overfill defects. • Do not leave defect open. • Do not compromise blood supply to the defect area. • The device should be secured to prevent motion and migration, use in areas where the graft can be adequately contained. • Do not pressure granules during delivery into the void gap. This can destruct the porous structure of DirectOss™.• DirectOss™ is intended for use by trained qualified persons familiar with bone grafting and having read this instruction for use. • Do not use if package is opened or damaged or if expiration date has been exceeded.

• Caution Federal (USA) law restricts this device to sale by or on the order of a licensed dentist. • MR statement DirectOss™ by SigmaGraft, Inc. has not been evaluated for safety and compatibility in

the MR environment. DirectOss™ has not been tested for heating or migration in the MR environment. • Rx Only

STORAGEDirectOss™ should be stored in a dry, clean and we ll ventilated place at ambient temperature (15-25oC/59-77oF). Keep the product in aseptic conditions until using the product.

EXPIRATION DATE : 3 years

LABELING SYMBOLS

SYMBOLS

DO NOT RE-USE

CAUTION, CONSULT ACCOMPANYING

DOCUMENTS BATCH CODE USE BY

CATALOG NUMBER MANUFACTURER DATE OF

MANUFACTURE STERILIZED USING IRRADIATION

TEMPERATURE LIMITATION

CE MARK & NOTIFIED BODY

NUMBER AUTHORIZED

REPRESENTATIVE IN THE EC

DO NOT RESTERILIZE

DO NOT USEIF PACKAGE

KEEP AWAY FROM SUNLIGHT KEEP DRY

CONSULT INSTRUCTIONS

FOR USE

Rx Only PRESCRIPTION ONLY

Latest revision date : 12/2013

27030 Malibu Hills Road Calabasas Hills, CA 91301Tel: 888-649-6425 Web site: www.implantdirect.com

Manufactured by Distributed byImplant Direct

25oC

15oC

IS DAMAGED

335 N. Puente St. Unit A Brea, CA 92821

Manufactured by SigmaGraft, Inc.