# K123876: Synergy

- Pathway: 510(k) (Traditional)
- Applicant: Odontit S.A.
- Decided: May 22, 2014 after 521 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
Longest line of descent: 3 generations back to K871773 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871773: Bio-Oss Pure Nat Hydroxyapatite Endoss Implant, Geistlich-Pharma (1987) Summary page 1.
- K952617: Bio-Oss, Geistlich-Pharma (1995) Summary page 1.
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 4.
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.
- K111816: Equimatrix, Luitpold Pharmaceuticals, Inc. (2011) Summary page 4.

## Indications for use
SYNERGY is intended for use in: Augmentation or reconstructive treatment of alveolar ridge Filling periodontal defects Filling defects after root resection, apicoectomy, and cystectomy Filling extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Source page: https://510kreport.com/device/K123876
Methodology: https://510kreport.com/methodology