Cleared Traditional

Premium Teeth Resin (K240538) - FDA 510(k) Clearance

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

K240538 · Formlabs Ohio, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
144d
Days
Class 2
Risk

K240538 is an FDA 510(k) clearance for the Premium Teeth Resin. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Formlabs Ohio, Inc. (Millbury, US). The FDA issued a Cleared decision on July 19, 2024 after a review of 144 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 Formlabs Ohio, Inc. devices

Submission Details

510(k) Number K240538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2024
Decision Date July 19, 2024
Days to Decision 144 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
17d slower than avg
Panel avg: 127d · This submission: 144d
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 62
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K240538.
TEMP MASTER, PMMA-based dental resin
K243951 · Taiwan Dental Materials Co., Ltd. · Feb 2025
PrimmaArt
K231859 · Dentscare Ltda · Nov 2024
Digital Temp
K242559 · Sprintray, Inc. · Nov 2024
Fixtemp® C&B 4:1
K241226 · Dreve Denatmid GmbH · May 2024
dima Print Teeth & Temp
K233868 · Kulzer, LLC · May 2024
PMMA BLOCK
K223706 · Huliang(Shanghai) Bio-Tech Co., Ltd. · May 2023