Cleared Traditional

K012160 - COMPCORE AF COMPOSITE CORE BUILD-UP MAT...

K012160 is the FDA 510(k) clearance for COMPCORE AF COMPOSITE CORE BUILD-UP MAT... by Premier Dental Products Co.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K012160 · Premier Dental Products Co. · Dental device
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Sep 2001
Decision
78d
Days
Class 2
Risk

K012160 is an FDA 510(k) clearance for the COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Belton, US). The FDA issued a Cleared decision on September 27, 2001 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Premier Dental Products Co. devices

Submission Details

510(k) Number K012160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2001
Decision Date September 27, 2001
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 425
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