Cleared Traditional

K905302 - DENTHESIVE

K905302 is an FDA 510(k) clearance for DENTHESIVE, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905302 · Kulzer, Inc. · Dental device
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Feb 1991
Decision
90d
Days
Class 2
Risk

K905302 is an FDA 510(k) clearance for the DENTHESIVE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 90 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K905302

510(k) Number K905302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date February 26, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 382
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K905302.
TOKUSO LIGHT BOND
K911525 · Tokuyama America, Inc. · May 1991
ALL-BOND 2
K910860 · Bisco, Inc. · Apr 1991
ALL BOND LINER-F
K910628 · Bisco, Inc. · Mar 1991
CONQUEST DIRECT FILLING COMPOSITE (DFC)
K904724 · Jeneric/Pentron, Inc. · Dec 1990
PERTAC UNIVERSAL BOND
K904289 · Espe GmbH (Us) · Nov 1990
DEGUFILL (TM) BOND
K902744 · Degussa AG · Aug 1990