# K011695: Collagen Dental Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Aug 7, 2001 after 68 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: 1 generation back to K960724 (1997). 1 ancestor in all.
15 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960724: Bio-Gide Resorbable Bilayer Membrane, Geistlich-Pharma (1997) Summary page 1.

## Most influential descendants
- K062881: Collagen Dental Menbrane - Conformable II (2006), 7 descendants of its own
- K090216: Collagen Dental Membrane IV (2009), 3 descendants of its own
- K051267: Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore Osseoquest Regenerative Membrane (2005), 3 descendants of its own
- K100156: Collagen Dental Membrane V (2010), 1 descendant of its own
- K091120: Medpor Contain Implant (2010), 1 descendant of its own

## Recalls of this device
- Mar 19, 2019 · Class II · Z-1389-2019: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

## Indications for use
Collagen Dental Membrane 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 post surgery.

Source page: https://510kreport.com/device/K011695
Methodology: https://510kreport.com/methodology