# K073685: Ota Collagen Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: Osseous Technologies of America
- Decided: Aug 29, 2008 after 245 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K112568: Aongen Dental Collagen Matrix (2012), 0 descendants of its own

## Indications for use
OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.

Source page: https://510kreport.com/device/K073685
Methodology: https://510kreport.com/methodology