Cleared Traditional

K931838 - DENTHESIVE II

K931838 is the FDA 510(k) clearance for DENTHESIVE II by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K931838 · Heraeus Kulzer, Inc. · Dental device
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Jul 1993
Decision
86d
Days
Class 2
Risk

K931838 is an FDA 510(k) clearance for the DENTHESIVE II. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 86 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 K931838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date July 08, 1993
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 297
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K931838.
BONDING RESIN PRODUCT LINE
K931870 · Ultradent Products, Inc. · Jul 1993
ALL-BOND(R) JR.
K932379 · Bisco, Inc. · Jul 1993
NEW DENTINE ADHESIVE
K931812 · Dentsply Intl. · Jul 1993
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
PULPDENT UNFILLED DUAL CURE BONDING RESIN
K930989 · Pulpdent Corp. · Apr 1993
RESTOBOND 4
K924378 · Lee Pharmaceuticals · Mar 1993