Cleared Traditional

K990363 - BIOMESH BIODEGRADABLE GTR BARRIER

K990363 is an FDA 510(k) clearance for BIOMESH BIODEGRADABLE GTR BARRIER, manufactured by Samyang Corp.. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990363 · Samyang Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
63d
Days
Class 2
Risk

K990363 is an FDA 510(k) clearance for the BIOMESH BIODEGRADABLE GTR BARRIER. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Samyang Corp. (Pleasant Hill, US). The FDA issued a Cleared decision on April 9, 1999 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Samyang Corp. devices

FDA 510(k) Submission Details - K990363

510(k) Number K990363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date April 09, 1999
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPK Device Classification - Class 2, Special Controls

Product Code NPK Barrier, Synthetic, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.
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 - NPK Barrier, Synthetic, Intraoral

All 21
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K990363.
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