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510(k) Data Aggregation
K Number
K103081Device Name
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
Manufacturer
Date Cleared
2012-03-02
(500 days)
Regulation Number
882.5275Why did this record match?
Applicant Name (Manufacturer) :
BIOM'UP SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Device Description
Cova™ORTHO-NERVE is a pure collagen membrane designed to be used as a barrier to allow guided healing along distinct anatomical planes. It is completely resorbable within a time frame that is compatible with healing. The membrane is obtained by standardized, controlled manufacturing processes. Cova™ORTHO-NERVE is further sterilized in double-pouches by gamma-irradiation. Cova™ORTHO-NERVE membranes are designed to be resorbable, non inflammatory and biocompatible for uses to treat peripheral nerve injuries. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™ORTHO-NERVE is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm, 30 x 40 mm and 40 x 60 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the zone to be treated.
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K Number
K103087Device Name
COVAMAX RESORBABLE COLLAGEN MEMBRANE
Manufacturer
Date Cleared
2011-08-26
(311 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
BIOM'UP SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in:
-Simultaneous use of GBR-membrane (Guided Bone Regeneration) and 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;
-Filling of bone defects after root resection, cystectomy and removal of retained teeth;
-Guided bone regeneration in dehiscence defects;
-Guided tissue regeneration procedures in periodontal and recession defects.
Device Description
Cova™MAX is a resorbable acellular membrane for guided tissue and bone regeneration in dental applications. Cova™MAX membranes are manufactured using a standardized, controlled process. Each Cova™MAX membrane is fabricated solely from Type I collagen extracted from veterinary certified pig tendon. Porcine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial quantities. It is packaged in a double package and sterilized by gamma irradiation.
Cova™MAX membranes serve as a barrier to guide the healing process between anatomic plans of tissues. It has been designed in accordance with the accepted principles or guided bone regeneration (GBR) as a wound healing material post surgery. They are designed to be resorbable, non inflammatory and biocompatible for uses in clinical periodontics.
The Cova™MAX membrane is completely resorbable within a timeframe compatible with the healing process. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™MAX is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm and 30 x 40 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the periodontal defect or zone to be treated.
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