Cleared Traditional

K132255 - ULTRACEM

K132255 is an FDA 510(k) clearance for ULTRACEM, manufactured by Ultradent Products Inc. / Oratech, LLC. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K132255 · Ultradent Products Inc. / Oratech, LLC · Dental device
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Oct 2013
Decision
97d
Days
Class 2
Risk

K132255 is an FDA 510(k) clearance for the ULTRACEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ultradent Products Inc. / Oratech, LLC (South Jordan, US). The FDA issued a Cleared decision on October 24, 2013 after a review of 97 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 Ultradent Products Inc. / Oratech, LLC devices

FDA 510(k) Submission Details - K132255

510(k) Number K132255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2013
Decision Date October 24, 2013
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
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 354
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