Cleared Traditional

K941572 - FLUORIDE-PSA PRIME/ADHESIVE

K941572 is an FDA 510(k) clearance for FLUORIDE-PSA PRIME/ADHESIVE, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K941572 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
71d
Days
Class 2
Risk

K941572 is an FDA 510(k) clearance for the FLUORIDE-PSA PRIME/ADHESIVE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 71 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K941572

510(k) Number K941572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date June 10, 1994
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 K941572.
PERMAGEN F/DC
K943373 · Ultradent Products, Inc. · Aug 1994
V-PRIMER
K942017 · Parkell, Inc. · Jul 1994
SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM
K942493 · 3M Company · Jul 1994
OPTIBOND
K940513 · Kerr Corporation (Danbury) · Apr 1994
DENTIN CONDITIONING AND ADHESIVE SYSTEM
K936222 · Jeneric/Pentron, Inc. · Mar 1994
GC FUJI COAT LC
K935961 · GC America, Inc. · Mar 1994