# K062846: Collagen Dental Membrane Iii

- Pathway: 510(k) (Special)
- Applicant: Collagen Matrix, Inc.
- Decided: Oct 13, 2006 after 21 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: 2 generations back to K960724 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011695: Collagen Dental Membrane, Collagen Matrix, Inc. (2001)

## Recalls of this device
- Aug 16, 2018 · Class III · Z-0414-2019: There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between 

## Indications for use
Collagen Dental Membrane III is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

Source page: https://510kreport.com/device/K062846
Methodology: https://510kreport.com/methodology