Studies SubmittedRomagnaGenon C Comparative Clinical Study of Guided Tissue Regeneration with aBioabsorbable Bilayer Collagen Membrane and Subepithelial Connective Tissue Graft JPeriodontol 72 ID: 855198
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1 reactions. BIO-GIDE® is sterilized in do
reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface -facing the bone -allows theingrowth of bone forming cells. The dense surface -facing the soft tissue -prevents theingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type Iand type III without further cross-linking or chemical treatment.6. BASIS FOR SUBSTANTIAL EQUIVALENCEBIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration issubstantially equivalent to Geistlich's existing product, BIO-GIDE® (K960724), andBioMend ExtendTM (K992216). The only difference between the new product and theBIG-GIDE® product previously cleared is the additional indication for guided tissueregeneration in p
2 eriodontal defects. ("GTR"). The followi
eriodontal defects. ("GTR"). The following is a table comparing BIG-GIDE® to BioMend ExtendTM, a collagen membrane cleared for GTR.Table I: BioMend ExtendTM Absorbable Collagen Membrane (Predicate Device) vs. BID-GIDE® Resorbable Bilayer MembraneComparison ChartUsed for guided tissue Used for guided tissueregeneration procedures in regeneration procedures inperiodontal defects to enhance periodontal defects to enhanceregeneration of the periodontal regeneration of the periodontalR~~'g4IN ~~~apparatus. apparatus.Yes YesCell occlusv Cell occlusiveImplantable Implantable[~ ~ ~~ ~. ~7! ~Resorbable ResorbableHemostatic HemostaticYes, yeI Coll-iagen Yes, Type I and Type IIICollagen!ETO Gamma Irradiation~~~~~~~YesYe~~~~~~~~~YesYe~ 24 M~~~~~~~ onths 36 Months-2-25121201\V-
3 2 Studies Submitted:Romagna-Genon, C., C
2 Studies Submitted:Romagna-Genon, C., Comparative Clinical Study of Guided Tissue Regeneration with aBioabsorbable Bilayer Collagen Membrane and Subepithelial Connective Tissue Graft, J.Periodontol, 72 (9), p. 1258-1264. (2001)Lekovic, V., et. al., Effectiveness of a Combination of Platelet-Rich Plasma, Bovine PorousBone Mineral and Guided Tissue Regeneration in the Treatment of Mandibular Grade II MolarFurcations in 1lumans, J Clin. Periodontol, (30), p. 746-51. (2003)Houser, B.E., et. al., Clinical Evaluation of Anorganic Bovine Bone Xenograft with aBioabsorbable Collagen Barrier in the Treatment of Molar Furcation Defects, The Int'l ofPeriodontics & Restorative Dentistry, 21(2), p. 161-69. (2001)Camargo, P.M., et. al., A Controlled Re-Entry Study on the Effecti
4 veness of Bovine PorousBone Mineral Used
veness of Bovine PorousBone Mineral Used in Combination with a Collagen membrane of Porcine Origin in theTreatment of Intrabony Defects in Humans, ] Clin. Periodontol (27), p. 889-896. (2000)Sculean, A., et. al., Healing of Intrabony Defects Following Treatment with a Bovine DerivedXenograft and Collagen Membrane, J Clin. Periodontol (30), p. 73-80. (2003)Tonetti, M.S., et. al., Clinical Outcomes Following Treatment of Human Intrabony Defects withGTR/Bone. Replacement Material or Access Flap Alone, ] Clin. Periodontol (To Be Published)Camelo, M., Nevins, M.L., et. al., Clinical, Radiographic, and Histologic Evaluation of HumanPeriodontal Defects Treated with BIO-OSS® and BIO-GIDE®, The Int'l ofPeriodontics &Restorative Dentistry, 18(4), p. 321-331. (1998)Camelo, M.
5 , Periodontal Regeneration with an Autog
, Periodontal Regeneration with an Autogenous Bone-BIO-OSS® Composite Graftand a BIO-GIDE® Membrane, The Int'l of Periodontics & Restorative Dentistry, 21(2), p.109-119. (2001)Yamada, Satoru, Effect of Porous Xenographic Bone Graft with Collagen Barrier Membrane onPeriodontal Regeneration, The Int'l of Periodontics & Restorative Dentistry, 22(4), p. 389-397.(2002)Nevins, M.L., et. al., Evaluation of Periodontal Regeneration Following Grafting IntrabonyDefects with BIO-OSS® Collagen: A Human Histologic Report, The Int'l] ofPeriodontics &Restorative Dentistry, 23(1), p. 9-17. (2003)-3-25121201WV.2 ko aqlqIndications for Use510(k) Number (if known): K01© ,'7Device Name: BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and BoneRegeneration.Indications for Use: S
6 imultaneous use of GBR-membrane and impl
imultaneous use of GBR-membrane and implants; augmentation aroundimplants placed in immediate extraction sockets; augmentation aroundimplants placed in delayed extraction sockets; localized ridgeaugmentation for later implantation; alveolar ridge reconstruction forprosthetic treatment; filling of bone defects after root resection,cystectomy, removal of retained teeth; guided bone regeneration indehiscence defects; guided tissue regeneration procedures in periodontaldefects.(Divsin s~crvOff)Division of AnestheSiology, General HOSPItal,Infection Control, Dental Devices510(k) Number: lqa -Prescription Use X AND/OR Over-The-Counter Use(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OFNEEDED)-14-25121201\V