Cleared Traditional

K902392 - COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL

K902392 is an FDA 510(k) clearance for COLTOSOL TEMPORARY ENDODONTIC FILLING M..., manufactured by Coltene, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K902392 · Coltene, Inc. · Dental device
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Aug 1990
Decision
90d
Days
Class 2
Risk

K902392 is an FDA 510(k) clearance for the COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Coltene, Inc. (Chicago, US). The FDA issued a Cleared decision on August 28, 1990 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 872.3275 - 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 Coltene, Inc. devices

FDA 510(k) Submission Details - K902392

510(k) Number K902392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date August 28, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
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.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K902392.
TEMPORARY DENTAL CEMENT
K904034 · Medical Device Inspection Co., Inc. · Dec 1990
CEMPER
K904024 · Scientific Pharmaceuticals, Inc. · Nov 1990
CHEMFIL II CAPS
K901524 · Dentsply Intl. · Sep 1990
SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST
K902817 · Confi-Dental Products Co. · Aug 1990
POST CEMENT (DENTAL COMPOSITE)
K902894 · Medical Device Inspection Co., Inc. · Aug 1990
AHYDRON DENTAL CLEANING AGENT
K902052 · Ivoclar North America, Inc. · Jul 1990