510(k) K254210
K254210 is an FDA 510(k) premarket notification submitted by Hyundai Bioland Co., Ltd. for the device "REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)". The FDA issued a decision of Substantially Equivalent on Sep 25, 2026. The device falls under product code NPM (Bone Grafting Material, Animal Source), a Class II device regulated under 21 CFR 872.3930.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2026
- Date Received
- Dec 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Grafting Material, Animal Source
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
- 510(k)
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.