Cleared Traditional

K243621 - Evoblock, Perléon (FDA 510(k) Clearance)

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

K243621 · Evoden Ind?stria Com?rcio Importa??o E Exporta??o · Dental device
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Apr 2025
Decision
151d
Days
Class 2
Risk

K243621 is an FDA 510(k) clearance for the Evoblock, Perléon. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Evoden Ind?stria Com?rcio Importa??o E Exporta??o (Pirassununga, BR). The FDA issued a Cleared decision on April 22, 2025 after a review of 151 days - an extended review cycle.

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 Evoden Ind?stria Com?rcio Importa??o E Exporta??o devices

Submission Details

510(k) Number K243621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2024
Decision Date April 22, 2025
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
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

Regulatory Insight, Inc.
Kevin Walls

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 188
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K243621.
Dura-Arch
K261261 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
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TempFIT Temporary Crown and Bridge Resin
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K243370 · Asiga Pty, Ltd. · May 2025
TEMP MASTER, PMMA-based dental resin
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PrimmaArt
K231859 · Dentscare Ltda · Nov 2024