510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K254210Substantially Equivalent

Rebohil (Bgm-1, Bgm-2, Bgm-3, Bgm-4, Bgm-5)

Hyundai Bioland Co., Ltd., Cheongju-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(270 days to decision)
Product code
NPM Bone Grafting Material, Animal Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Hyundai Bioland Co., Ltd. 162, Gwahaksaneop 3-Ro, Ochang-Eup, Cheongwon-Gu, Cheongju-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPM

Trailing 12 months
2 clearances under product code NPM in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NPM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260