Cleared Traditional

MD-Temp Plus (K190724) - FDA 510(k) Clearance

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

K190724 · Meta Biomed Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
105d
Days
Class 2
Risk

K190724 is an FDA 510(k) clearance for the MD-Temp Plus. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Meta Biomed Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on July 3, 2019 after a review of 105 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 Meta Biomed Co., Ltd. devices

Submission Details

510(k) Number K190724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2019
Decision Date July 03, 2019
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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

Withus Group, Inc.
April Lee

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 48
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K190724.
Ceramill A-Temp
K191843 · Amann Girrbach AG · Oct 2019
TurboTemp EZ
K191619 · Zest Anchors, LLC · Sep 2019
SmarTemp X1
K190930 · Parkell, Inc. · Sep 2019
LuxaCrown, Shade A1, A2, A3, A3.5
K183337 · Dmg Chemisch Pharmazeutische Fabrik GmbH · May 2019
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · Blue Dent Dental · Dec 2018
Harvest Dental Polymer Blocks
K180578 · Harvest Dental Products, LLC · Dec 2018