Cleared Traditional

K102917 - FIXTEMP C&B

K102917 is an FDA 510(k) clearance for FIXTEMP C&B, manufactured by Exacta Dental Direct, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K102917 · Exacta Dental Direct, Inc. · Dental device
Download Printable Device Report (PDF)
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Jun 2011
Decision
259d
Days
Class 2
Risk

K102917 is an FDA 510(k) clearance for the FIXTEMP C&B. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Exacta Dental Direct, Inc. (Stamford, US). The FDA issued a Cleared decision on June 17, 2011 after a review of 259 days - an extended review 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: 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 Exacta Dental Direct, Inc. devices

FDA 510(k) Submission Details - K102917

510(k) Number K102917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date June 17, 2011
Days to Decision 259 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 127d · This submission: 259d
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 118
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K102917.
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