Cleared Traditional

GLUMA DESENSITIZER/GLUMA 3 PRIMER (K962812) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 98
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K962812.
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
K964038 · Heraeus Kulzer, Inc. · Apr 1997
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
K964525 · Dentsply Intl. · Jan 1997
GLUMA CONDITIONER
K964140 · Heraeus Kulzer, Inc. · Nov 1996
3M DENT SYSTEM
K962785 · 3M Company · Aug 1996
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K962348 · Dentsply Intl. · Jul 1996
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K960823 · Dentsply Intl. · Apr 1996