# K090794: Osteotape

- Pathway: 510(k) (Traditional)
- Applicant: Impladent, Ltd.
- Decided: Dec 10, 2009 after 261 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with OsteoTape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®.

Source page: https://510kreport.com/device/K090794
Methodology: https://510kreport.com/methodology