Cleared Traditional

K192830 - Bright Temporary C&B

K192830 is an FDA 510(k) clearance for Bright Temporary C&B, manufactured by Dmp Dental Industry S.A.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K192830 · Dmp Dental Industry S.A. · Dental device
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Sep 2020
Decision
336d
Days
Class 2
Risk

K192830 is an FDA 510(k) clearance for the Bright Temporary C&B. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on September 2, 2020 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dental Industry S.A. devices

FDA 510(k) Submission Details - K192830

510(k) Number K192830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2019
Decision Date September 02, 2020
Days to Decision 336 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 127d · This submission: 336d
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 111
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K192830.
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ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
K200676 · Zirkonzahn Srl · Jul 2020