Cleared Traditional

K112186 - FIBER DISK AND BLOCK

K112186 is an FDA 510(k) clearance for FIBER DISK AND BLOCK, manufactured by Bioloren S.R.L.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K112186 · Bioloren S.R.L. · Dental device
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Nov 2011
Decision
102d
Days
Class 2
Risk

K112186 is an FDA 510(k) clearance for the FIBER DISK AND BLOCK. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Bioloren S.R.L. (Saronno, IT). The FDA issued a Cleared decision on November 8, 2011 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 - K112186

510(k) Number K112186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date November 08, 2011
Days to Decision 102 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
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 118
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