MEDIUMRegulatoryTier 1
FDA 510(k) K254210: REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices using animal-derived bone grafting materials now have one additional FDA-cleared option (REBOHIL) for alveolar ridge preservation and sinus augmentation; owners and surgical teams should verify supplier credentials and pricing before switching.
Key points
- Device cleared via traditional 510(k) K254210 as substantially equivalent to predicate devices under 21 CFR 872.3930 (product code NPM).
- Hyundai Bioland Co., Ltd. is the manufacturer; product marketed as REBOHIL in five models (BGM-1 through BGM-5).
- Class II animal-source bone graft indicated for dental implant site preparation and periodontal defects.
- Clearance adds competitive supply option; no recall or safety alert accompanies this entry.
Who should care
OwnerSpecialist
Read the original on openFDA Dental Devices
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