Cleared Traditional

VERACIA

K121749 · Shofu Dental Corporation · Dental
Sep 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K121749 is an FDA 510(k) clearance for the VERACIA, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on September 7, 2012, 85 days after receiving the submission on June 14, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number K121749 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2012
Decision Date September 07, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELM — Denture, Plastic, Teeth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3590

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