Cleared Traditional

K243951 - TEMP MASTER, PMMA-based dental resin (FDA 510(k) Clearance)

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

K243951 · Taiwan Dental Materials Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
60d
Days
Class 2
Risk

K243951 is an FDA 510(k) clearance for the TEMP MASTER, PMMA-based dental resin. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Taiwan Dental Materials Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 21, 2025 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Taiwan Dental Materials Co., Ltd. devices

Submission Details

510(k) Number K243951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date February 21, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
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

All 188
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K243951.
Dura-Arch
K261261 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
“FLNT Base” and “FLNT Temp”
K253380 · Liaoning Upcera Co., Ltd. · Mar 2026
TempFIT Temporary Crown and Bridge Resin
K251271 · Rizhao Huge Biomaterials Company, Ltd. · Jun 2025
DentaTOOTH
K243370 · Asiga Pty, Ltd. · May 2025
Evoblock, Perléon
K243621 · Evoden Ind?stria Com?rcio Importa??o E Exporta??o · Apr 2025
PrimmaArt
K231859 · Dentscare Ltda · Nov 2024