Cleared Traditional

VINTAGE PRO

K181496 · Shofu Dental Corporation · Dental
Dec 2018
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K181496 is an FDA 510(k) clearance for the VINTAGE PRO, 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 December 18, 2018, 194 days after receiving the submission on June 7, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K181496 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2018
Decision Date December 18, 2018
Days to Decision 194 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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