Cleared Traditional

K962515 - KERR ADVANCED ADHESIVE

K962515 is an FDA 510(k) clearance for KERR ADVANCED ADHESIVE, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K962515 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
35d
Days
Class 2
Risk

K962515 is an FDA 510(k) clearance for the KERR ADVANCED ADHESIVE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 35 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K962515

510(k) Number K962515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1996
Decision Date August 01, 1996
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
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 343
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K962515.
GLUMA DESENSITIZER/GLUMA 3 PRIMER
K962812 · Heraeus Kulzer, Inc. · Oct 1996
EBS (ESPE BONDING SYSTEM)
K962428 · Espe GmbH & Co. Kg. · Sep 1996
3M DENT SYSTEM
K962785 · 3M Company · Aug 1996
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
K960696 · Ultradent Products, Inc. · Jul 1996
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K962348 · Dentsply Intl. · Jul 1996
WET-PREP
K961822 · Bisco, Inc. · Jun 1996