Cleared Traditional

TEFGEN GUIDED TISSUE MEMBRANE (K964656) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964656 · American Custom Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
82d
Days
Class 2
Risk

K964656 is an FDA 510(k) clearance for the TEFGEN GUIDED TISSUE MEMBRANE. 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 February 10, 1997 after a review of 82 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 American Custom Medical, Inc. devices

Submission Details

510(k) Number K964656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date February 10, 1997
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
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.