Cleared Traditional

K041098 - COOL TEMP NATURAL

K041098 is an FDA 510(k) clearance for COOL TEMP NATURAL, manufactured by Coltene AG. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K041098 · Coltene AG · Dental device
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May 2004
Decision
16d
Days
Class 2
Risk

K041098 is an FDA 510(k) clearance for the COOL TEMP NATURAL. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Coltene AG (New York, US). The FDA issued a Cleared decision on May 13, 2004 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Coltene AG devices

FDA 510(k) Submission Details - K041098

510(k) Number K041098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2004
Decision Date May 13, 2004
Days to Decision 16 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 138
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K041098.
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