# K090793: Bongros HA

- Pathway: 510(k) (Traditional)
- Applicant: Bioalpha, Inc.
- Decided: May 19, 2009 after 56 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981182: Osteograf/N-300, Ceramed Dental, LLC (1998) Summary page 1.
- K980679: Endobon, Biomet, Inc. (1998) Summary page 1.
- K072397: Synoss Synthetic Bone Graft Material, Collagen Matrix, Inc. (2007) Summary page 1.
- K952619: Bio-Oss Ceramic, Geistlich-Pharma (1995) Summary page 1.

## Indications for use
Bongros®-HA (HAGS, HAGM, HAGL) is intended for use in dental surgery. The products may be used in surgical procedures such as: Augmentation or reconstructive treatment of the alveolar ridge Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of the maxillary sinus floor Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

Source page: https://510kreport.com/device/K090793
Methodology: https://510kreport.com/methodology