Cleared Traditional

VINTAGE LD

K152392 · Shofu Dental Corporation · Dental
Jan 2016
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K152392 is an FDA 510(k) clearance for the VINTAGE LD, 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 January 8, 2016, 137 days after receiving the submission on August 24, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K152392 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2015
Decision Date January 08, 2016
Days to Decision 137 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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