Cleared Traditional

K182065 - EVOLUX CAD/CAM PMMA BLOCKS

K182065 is the FDA 510(k) clearance for EVOLUX CAD/CAM PMMA BLOCKS by Blue Dent Dental. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K182065 · Blue Dent Dental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Blue Dent Dental devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 127d · 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 Consultant

Passarini Regulatory Affairs of America, LLC
Mauro Malzyner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 91
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K182065.
SmarTemp X1
K190930 · Parkell, Inc. · Sep 2019
MD-Temp Plus
K190724 · Meta Biomed Co., Ltd. · Jul 2019
LuxaCrown, Shade A1, A2, A3, A3.5
K183337 · Dmg Chemisch Pharmazeutische Fabrik GmbH · May 2019
Harvest Dental Polymer Blocks
K180578 · Harvest Dental Products, LLC · Dec 2018
Resin for Temporary Crown & Bridge
K180657 · Dentis Co., Ltd. · Dec 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018