Cleared Traditional

K964525 - PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BON...

K964525 is the FDA 510(k) clearance for PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BON... by Dentsply Intl.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964525 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
71d
Days
Class 2
Risk

K964525 is an FDA 510(k) clearance for the PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR. 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 January 22, 1997 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

Submission Details

510(k) Number K964525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date January 22, 1997
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.

Device Classification

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 289
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K964525.
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
K964038 · Heraeus Kulzer, Inc. · Apr 1997
DENTINSENSE B/C
K965138 · Centrix, Inc. · Feb 1997
DENTINSENSE
K964735 · Centrix, Inc. · Feb 1997
BISFIL 2B
K964000 · Bisco, Inc. · Nov 1996
GLUMA CONDITIONER
K964140 · Heraeus Kulzer, Inc. · Nov 1996
GLUMA DESENSITIZER/GLUMA 3 PRIMER
K962812 · Heraeus Kulzer, Inc. · Oct 1996