Cleared Abbreviated

K121769 - DENTOCORE / DENTOCORE BODY

K121769 is an FDA 510(k) clearance for DENTOCORE / DENTOCORE BODY, manufactured by Itena Clinical. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 263-day FDA review.

K121769 · Itena Clinical · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
263d
Days
Class 2
Risk

K121769 is an FDA 510(k) clearance for the DENTOCORE / DENTOCORE BODY. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Itena Clinical (Laval, CA). The FDA issued a Cleared decision on March 5, 2013 after a review of 263 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K121769

510(k) Number K121769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2012
Decision Date March 05, 2013
Days to Decision 263 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
136d slower than avg
Panel avg: 127d · This submission: 263d
Pathway characteristics
Standards-based clearance path.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 685
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