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510(k) Data Aggregation
K Number
K101453Device Name
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
Manufacturer
OBI BIOLOGICS, INC.
Date Cleared
2011-07-21
(422 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OBI BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitala™ Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:
- Simultaneous use with implants;
- Augmentation around implants placed in immediate extraction sockets;
- Augmentation around implants placed in delayed extraction sockets;
- Localized ridge augmentation for later implantation;
- Alveolar ridge reconstruction for prosthetic treatment;
- Alveolar ridge preservation consequent to tooth extraction;
- Filling of bone defects after root resection, cystectomy, removal of retained teeth;
- Over the window in lateral window sinus elevation procedures;
- Furcation defects in multi-rooted teeth;
- Treatment of recession defects, together with coronally positioned flap;
- In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection;
- Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration in periodontal defects.
Device Description
Vitala™ Resorbable Natural Collagen Membrane is a natural collagen membrane sourced from veterinary certified pigs. Vitala™ Resorbable Natural Collagen Membrane, minimally manipulated without further cross-linking, is sterilized in a double tray package configuration via E-beam irradiation.
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