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K Number
K141177Device Name
VITALA PORCINE DERIVED COLLAGEN MEMBRANE
Manufacturer
OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI
Date Cleared
2015-09-15
(496 days)
Product Code
NPL
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitala® Porcine Derived 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® Porcine Derived Collagen Membrane is a natural collagen membrane for use in periodontal and/or dental surgical procedures. The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks.
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