Cleared Traditional

K191590 - AA temp temporary restoration 3D printi...

K191590 is the FDA 510(k) clearance for AA temp temporary restoration 3D printi... by Enlighten Materials Co., Ltd.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K191590 · Enlighten Materials Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
326d
Days
Class 2
Risk

K191590 is an FDA 510(k) clearance for the AA temp temporary restoration 3D printing photoreactive resin. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Enlighten Materials Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on May 5, 2020 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Enlighten Materials Co., Ltd. devices

Submission Details

510(k) Number K191590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date May 05, 2020
Days to Decision 326 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
199d slower than avg
Panel avg: 127d · This submission: 326d
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

Voler Biotech Consulting CO., Ltd.
Chih-Hao Kao

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 K191590.
GC Temp Print
K193113 · GC America, Inc. · Jul 2020
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K200676 · Zirkonzahn Srl · Jul 2020
VarseoSmile Temp
K193553 · Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG · May 2020
DiaTemp Flow
K192022 · DiaDent Group International · Feb 2020
DiaTemp
K192158 · DiaDent Group International · Feb 2020
DENTCA Crown and Bridge
K192806 · Dentca, Inc. · Feb 2020