# K103087: Covamax Resorbable Collagen Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Biom'Up Sas
- Decided: Aug 26, 2011 after 311 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924408 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2004) Summary page 1.
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 1.

## Recalls of this device
- Dec 2, 2016 · Class II · Z-1110-2017: Lack of sterility assurance

## Indications for use
Cova' hMAX is intended for use in oral surgicM 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 dlehiscence defects; -Guided tissue regeneration procedures in periodontal and recession defects.

Source page: https://510kreport.com/device/K103087
Methodology: https://510kreport.com/methodology