Cleared Traditional

K954133 - AMERICAN DENTAL PRODUCTS WETTING AGENT ...

K954133 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS WETTING AGENT ..., manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K954133 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
59d
Days
Class 2
Risk

K954133 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Medinah, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 - K954133

510(k) Number K954133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date October 30, 1995
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K954133.
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
K960365 · Wallace A. Erickson & Co. · Mar 1996
AMALGAMIBOND PLUS
K960879 · Parkell, Inc. · Mar 1996
D-SENSE
K955279 · Centrix, Inc. · Dec 1995
SILANE PRIMER
K954708 · Sybron Dental Specialties, Inc. · Oct 1995
IMPERVA FLUOROBOND
K953612 · Shofu Dental Corp. · Oct 1995
IMPERVA ENSURABOND
K953613 · Shofu Dental Corp. · Oct 1995