Cleared Traditional

K955838 - ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)

K955838 is an FDA 510(k) clearance for ATRISORB BIOABSORBABLE GUIDED TISSUE RE..., manufactured by Atrix Laboratories, Inc.. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955838 · Atrix Laboratories, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
90d
Days
Class 2
Risk

K955838 is an FDA 510(k) clearance for the ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR). Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Atrix Laboratories, Inc. (Fort Collins, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 90 days - within the typical 510(k) review window.

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 Atrix Laboratories, Inc. devices

FDA 510(k) Submission Details - K955838

510(k) Number K955838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date March 21, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 22
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K955838.
TEFGEN GUIDED TISSUE MEMBRANE
K964656 · American Custom Medical, Inc. · Feb 1997
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 REGENERATIVE MATERIAL
K922627 · W.L. Gore & Associates, Inc. · Jun 1994
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