Cleared Traditional

K191590 - AA temp temporary restoration 3D printing photoreactive resin

K191590 is an FDA 510(k) clearance for AA temp temporary restoration 3D printi..., manufactured by Enlighten Materials Co., Ltd.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K191590

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.

EBG Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K191590.
GC Temp Print
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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