Cleared Traditional

K182065 - EVOLUX CAD/CAM PMMA BLOCKS (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182065 · Blue Dent Dental · Dental device
Dec 2018
Decision
134d
Days
Class 2
Risk

K182065 is an FDA 510(k) clearance for the EVOLUX CAD/CAM PMMA BLOCKS. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Blue Dent Dental (Pirassununga, BR). The FDA issued a Cleared decision on December 13, 2018 after a review of 134 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.

Submission Details

510(k) Number K182065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date December 13, 2018
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 158d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K182065.
“FLNT Base” and “FLNT Temp”
K253380 · Liaoning Upcera Co., Ltd. · Mar 2026
TempFIT Temporary Crown and Bridge Resin
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DentaTOOTH
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Evoblock, Perléon
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