# K212509: OSSIX Breeze

- Pathway: 510(k) (Traditional)
- Applicant: Datum Dental, Ltd.
- Decided: Jul 18, 2022 after 343 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
Longest line of descent: 2 generations back to K053260 (2006). 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)
- K160281: Ossix Plus, Datum Dental, Ltd. (2016) Summary page 4.

## Indications for use
OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for: 1) Alveolar ridge augmentation and reconstruction, 2) Alveolar ridge preservation consequent to tooth extractions, 3) Over the window in sinus elevation procedures and for support of the Schneiderian membrane, 4) In intra bony defects around teeth, 5) Guided tissue regeneration procedures in periodontal defects.

Source page: https://510kreport.com/device/K212509
Methodology: https://510kreport.com/methodology