# K254210: Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

- Pathway: 510(k) (Traditional)
- Applicant: Hyundai Bioland Co., Ltd.
- Decided: Sep 25, 2026 after 270 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: 4 generations back to K871773 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142040: Ocs-B Collagen, Nibec Co., Ltd. (2015) Summary page 5.

## Indications for use
REBOHIL is intended for the following uses: - 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 the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for 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/K254210
Methodology: https://510kreport.com/methodology