Cleared Traditional

K191794 - Vintage Art Universal

K191794 is the FDA 510(k) clearance for Vintage Art Universal by Shofu Dental Corporation. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 260
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