Cleared Traditional

TURBO TEMP 3 (K102753) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102753 · Danville Materials, Inc. · Dental device
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Feb 2011
Decision
134d
Days
Class 2
Risk

K102753 is an FDA 510(k) clearance for the TURBO TEMP 3. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on February 4, 2011 after a review of 134 days - within the typical 510(k) review window.

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: 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 Danville Materials, Inc. devices

Submission Details

510(k) Number K102753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date February 04, 2011
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 188
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K102753.
Dura-Arch
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“FLNT Base” and “FLNT Temp”
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TempFIT Temporary Crown and Bridge Resin
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K243621 · Evoden Ind?stria Com?rcio Importa??o E Exporta??o · Apr 2025
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K243951 · Taiwan Dental Materials Co., Ltd. · Feb 2025