510(k) clearance
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
- 510(k) number
- K254210
- Applicant
- Hyundai Bioland Co., Ltd.
- Decision date
- Sep 25, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NPM
- Device type
- Bone Grafting Material, Animal Source
- Device class
- Class II
- Regulation
- 21 CFR 872.3930
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Cheongju-Si, KR