Cleared Traditional

K922627 - GORE-TEX REGENERATIVE MATERIAL

K922627 is the FDA 510(k) clearance for GORE-TEX REGENERATIVE MATERIAL by W.L. Gore & Associates, Inc.. It is a Class 2 Dental device (product code NPK) cleared through the Traditional 510(k) pathway after a 737-day FDA review.

K922627 · W.L. Gore & Associates, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
737d
Days
Class 2
Risk

K922627 is an FDA 510(k) clearance for the GORE-TEX REGENERATIVE MATERIAL. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 737 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K922627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date June 10, 1994
Days to Decision 737 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
610d slower than avg
Panel avg: 127d · This submission: 737d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K922627.
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
K051267 · W.L. Gore & Associates, Inc. · Jun 2005
VICRYL PERIDONTAL MESH
K955646 · Ethicon, Inc. · May 1996
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
K960292 · W.L. Gore & Associates, Inc. · Apr 1996
GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS
K933541 · W.L. Gore & Associates, Inc. · Nov 1993
GORE-TEX PERIODONTAL MATERIAL
K854299 · W.L. Gore & Associates, Inc. · May 1986