Cleared Traditional

K954373 - AMERICAN DENTAL PRODUCTS PASTE-PRIMER A...

K954373 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS PASTE-PRIMER A..., manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K954373 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
30d
Days
Class 2
Risk

K954373 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/F.... Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Medinah, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 - K954373

510(k) Number K954373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date October 19, 1995
Days to Decision 30 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
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 126
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K954373.
ORTHO-ONE
K962946 · Bisco, Inc. · Sep 1996
GC FUJI ORTHO
K961417 · GC America, Inc. · May 1996
RESILIENCE M5 PROTECTION PLUS
K955329 · Confi-Dental Products Co. · Mar 1996
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
K954374 · American Dental Products, Inc. · Oct 1995
AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
K954372 · American Dental Products, Inc. · Oct 1995
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE
K954244 · American Dental Products, Inc. · Oct 1995