Cleared Traditional

IPS Style Ceram, IPS Style Ceram One, IPS Style Press

K152103 · Ivoclar Vivadent, AG · Dental
May 2016
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K152103 is an FDA 510(k) clearance for the IPS Style Ceram, IPS Style Ceram One, IPS Style Press, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on May 20, 2016, 296 days after receiving the submission on July 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K152103 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2015
Decision Date May 20, 2016
Days to Decision 296 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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