Cleared Traditional

K962812 - GLUMA DESENSITIZER/GLUMA 3 PRIMER

K962812 is an FDA 510(k) clearance for GLUMA DESENSITIZER/GLUMA 3 PRIMER, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K962812 · Heraeus Kulzer, Inc. · Dental device
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Oct 1996
Decision
81d
Days
Class 2
Risk

K962812 is an FDA 510(k) clearance for the GLUMA DESENSITIZER/GLUMA 3 PRIMER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 81 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K962812

510(k) Number K962812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date October 07, 1996
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
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 K962812.
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
K964133 · American Dental Products, Inc. · Jan 1997
BISFIL 2B
K964000 · Bisco, Inc. · Nov 1996
GLUMA CONDITIONER
K964140 · Heraeus Kulzer, Inc. · Nov 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