Cleared Traditional

K951426 - AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL

K951426 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS (ADP), manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K951426 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
45d
Days
Class 2
Risk

K951426 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATI.... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Medinah, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K951426

510(k) Number K951426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1995
Decision Date May 12, 1995
Days to Decision 45 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
83d faster than avg
Panel avg: 128d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 836
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K951426.
COMPSEAL
K952500 · Jeneric/Pentron, Inc. · Jun 1995
COMPOLGLASS COMPOGLASS SCA
K951836 · Ivoclar North America, Inc. · May 1995
AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL
K951427 · American Dental Products, Inc. · May 1995
PERMASEAL
K950859 · Ultradent Products, Inc. · Mar 1995
DYRACT II RESTORATIVE
K950991 · Dentsply Intl. · Mar 1995
THERMORESIN LC II
K942993 · GC America, Inc. · Feb 1995