Cleared Traditional

K083304 - TEMPOSIL 2

K083304 is the FDA 510(k) clearance for TEMPOSIL 2 by Coltene/Whaledent AG. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K083304 · Coltene/Whaledent AG · Dental device
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Feb 2009
Decision
88d
Days
Class 2
Risk

K083304 is an FDA 510(k) clearance for the TEMPOSIL 2. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 88 days - a notably fast clearance cycle.

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: 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/Whaledent AG devices

Submission Details

510(k) Number K083304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date February 06, 2009
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.