Cleared Traditional

K121735 - FIBER DISK AND BLOCK PERMANENT

K121735 is an FDA 510(k) clearance for FIBER DISK AND BLOCK PERMANENT, manufactured by Bioloren S.R.L.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

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

FDA 510(k) Submission Details - K121735

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.

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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