Cleared Traditional

K960696 - PERMALUTE COMPOSITE LUTING/RESTORATIVE ...

K960696 is the FDA 510(k) clearance for PERMALUTE COMPOSITE LUTING/RESTORATIVE ... by Ultradent Products, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K960696 · Ultradent Products, Inc. · Dental device
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Jul 1996
Decision
149d
Days
Class 2
Risk

K960696 is an FDA 510(k) clearance for the PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 149 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K960696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date July 18, 1996
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K960696.
GLUMA CONDITIONER
K964140 · Heraeus Kulzer, Inc. · Nov 1996
GLUMA DESENSITIZER/GLUMA 3 PRIMER
K962812 · Heraeus Kulzer, Inc. · Oct 1996
3M DENT SYSTEM
K962785 · 3M Company · Aug 1996
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K962348 · Dentsply Intl. · Jul 1996
WET-PREP
K961822 · Bisco, Inc. · Jun 1996
ULTRACID AND ULTRACID F DISINFECTING SOLUTION
K960697 · Ultradent Products, Inc. · May 1996