Cleared Traditional

K191794 - Vintage Art Universal

K191794 is an FDA 510(k) clearance for Vintage Art Universal, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K191794 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
92d
Days
Class 2
Risk

K191794 is an FDA 510(k) clearance for the Vintage Art Universal. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on October 3, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Shofu Dental Corporation devices

FDA 510(k) Submission Details - K191794

510(k) Number K191794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date October 03, 2019
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K191794.
EthanZir Zirconia
K191304 · Besorah Dental Solutions NZ Limited · Nov 2019
ZMAXX Dental Zirconia Blanks
K191631 · Zmaxx Bioceramics, LLC · Nov 2019
Razor, Everest, U&C Liquid
K191902 · U&C International Co., Ltd. · Oct 2019
Shaders ZR
K190569 · Digital Age Dental Lab · Jul 2019
KATANA Zirconia Block
K190436 · Kuraray Noritake Dental, Inc. · May 2019
Dental Ceramic
K182350 · Baot Biological Technology Co., Ltd. · May 2019