# K142040: Ocs-B Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Nibec Co., Ltd.
- Decided: Jul 31, 2015 after 368 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.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092428: Bio-Oss Collagen, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2010) Summary page 4.

## Most influential descendants
- K254210: Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (2026), 0 descendants of its own
- K221808: InterOss Collagen (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K142040
Methodology: https://510kreport.com/methodology