Cleared Traditional

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

K254210 is an FDA 510(k) clearance for REBOHIL (BGM-1, manufactured by Hyundai Bioland Co., Ltd.. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K254210 · Hyundai Bioland Co., Ltd. · Dental device
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Sep 2026
Decision
270d
Days
Class 2
Risk

K254210 is an FDA 510(k) clearance for the REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5). Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Hyundai Bioland Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on September 25, 2026 after a review of 270 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Hyundai Bioland Co., Ltd. devices

FDA 510(k) Submission Details - K254210

510(k) Number K254210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date September 25, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 128d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPM Device Classification - Class 2, Special Controls

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NPM Bone Grafting Material, Animal Source

All 40
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K254210.
BOSS
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SwissGraft X
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Geistlich Bio-Flow®
K242510 · Geistlich Pharma AG · Mar 2025
Xenograft Bovine Bone Particulate
K240133 · Collagen Solutions, LLC · Aug 2024
THE Graft Collagen
K230305 · Purgo Biologics, Inc. · Jul 2024