Cleared Traditional

Vintage Art Universal

K191794 · Shofu Dental Corporation · Dental
Oct 2019
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K191794 is an FDA 510(k) clearance for the Vintage Art Universal, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on October 3, 2019, 92 days after receiving the submission on July 3, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K191794 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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