REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)— 510(k) K254210

Name: FDA 510(k) clearance K254210
Creator: U.S. Food and Drug Administration
Published: 2026-09-25

Substantially Equivalent

Hyundai Bioland Co., Ltd.

FDA 510(k) clearance K254210 for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5), Substantially Equivalent on 2026-09-25. Applicant: Hyundai Bioland Co., Ltd.. Device class: 2.

Summary

REBOHIL is a dental bone graft material in five variants, BGM-1 through BGM-5. It's filed under NPM, animal-source bone grafting material. The record doesn't name the animal source or say how the five variants differ.

Class II, 21 CFR 872.3930, Dental panel, Traditional 510(k).

Hyundai Bioland Co., Ltd. filed from Cheongju-Si, South Korea. Review took 270 days (December 29, 2025 to September 25, 2026).

Clearance details

Applicant: Hyundai Bioland Co., Ltd.
Product code: Product code NPM
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2025-12-29
Decision date: 2026-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.