Cleared Traditional

K102257 - NANOCERAM- BRIGHT

K102257 is an FDA 510(k) clearance for NANOCERAM- BRIGHT, manufactured by Dmp, Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K102257 · Dmp, Ltd. · Dental device
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Nov 2010
Decision
101d
Days
Class 2
Risk

K102257 is an FDA 510(k) clearance for the NANOCERAM- BRIGHT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dmp, Ltd. (Markopoulo, Attiki, GR). The FDA issued a Cleared decision on November 19, 2010 after a review of 101 days - within the typical 510(k) review window.

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 Dmp, Ltd. devices

FDA 510(k) Submission Details - K102257

510(k) Number K102257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date November 19, 2010
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
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.