Cleared Abbreviated

K122551 - PROVITEMP

K122551 is an FDA 510(k) clearance for PROVITEMP, manufactured by Itena Clinical. The device is a Class 2 Dental device with product code EMA cleared through the Abbreviated 510(k) pathway after a 297-day FDA review.

K122551 · Itena Clinical · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
297d
Days
Class 2
Risk

K122551 is an FDA 510(k) clearance for the PROVITEMP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Itena Clinical (Laval, CA). The FDA issued a Cleared decision on June 14, 2013 after a review of 297 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Itena Clinical devices

FDA 510(k) Submission Details - K122551

510(k) Number K122551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2012
Decision Date June 14, 2013
Days to Decision 297 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 127d · This submission: 297d
Pathway characteristics
Standards-based clearance path.

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 350
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K122551.
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