Cleared Traditional

K954637 - AMERICAN DENTAL PRODUCTS TISSUE CONDITI...

K954637 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS TISSUE CONDITI..., manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954637 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
83d
Days
Class 2
Risk

K954637 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Medinah, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Dental Products, Inc. devices

FDA 510(k) Submission Details - K954637

510(k) Number K954637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1995
Decision Date December 28, 1995
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 156
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K954637.
V.R.S. DENTURE RESIN MATERIAL
K962333 · Vident · Aug 1996
QUICKSPLINT
K961995 · Heraeus Kulzer, Inc. · Jun 1996
BOSWORTH LIQUID RESIN II
K961200 · Harry J. Bosworth Co. · May 1996
CONNECT
K954689 · Sybron Dental Specialties, Inc. · Oct 1995
PALASPLINT
K953743 · Heraeus Kulzer, Inc. · Oct 1995
PROP. CONQUEST C&B VLC GLAZE/SEALANT
K953381 · Jeneric/Pentron, Inc. · Sep 1995