Cleared Traditional

K121735 - FIBER DISK AND BLOCK PERMANENT, TRINIA (FDA 510(k) Clearance)

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

K121735 · Bioloren S.R.L. · Dental device
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Feb 2013
Decision
253d
Days
Class 2
Risk

K121735 is an FDA 510(k) clearance for the FIBER DISK AND BLOCK PERMANENT, TRINIA. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bioloren S.R.L. (Saronno, Va, IT). The FDA issued a Cleared decision on February 21, 2013 after a review of 253 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 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 Bioloren S.R.L. devices

Submission Details

510(k) Number K121735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2012
Decision Date February 21, 2013
Days to Decision 253 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
126d slower than avg
Panel avg: 127d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 926
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K121735.
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