Cleared Traditional

K965205 - TEFGEN - LS

K965205 is an FDA 510(k) clearance for TEFGEN - LS, manufactured by American Custom Medical, Inc.. The device is a Class 2 Dental device with product code NPK cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K965205 · American Custom Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
125d
Days
Class 2
Risk

K965205 is an FDA 510(k) clearance for the TEFGEN - LS. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by American Custom Medical, Inc. (Bozeman, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 125 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 American Custom Medical, Inc. devices

FDA 510(k) Submission Details - K965205

510(k) Number K965205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1996
Decision Date April 30, 1997
Days to Decision 125 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
2d faster than avg
Panel avg: 127d · This submission: 125d
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 14
Devices cleared under the same product code (NPK) and FDA review panel - the closest regulatory comparables to K965205.
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE
K051267 · W.L. Gore & Associates, Inc. · Jun 2005
IMTEC/BIOBARRIER MEMBRANE
K974752 · Imtec Corp. · Mar 1998
IMTEC BIOBARRIER MEMBRANE
K972240 · Imtec Corp. · Aug 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