Cleared Traditional

IRIS - HIGH STRENGTH GLASS CERAMIC

K123615 · Dentsply Intl. · Dental
Feb 2013
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K123615 is an FDA 510(k) clearance for the IRIS - HIGH STRENGTH GLASS CERAMIC, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on February 22, 2013, 91 days after receiving the submission on November 23, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K123615 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2012
Decision Date February 22, 2013
Days to Decision 91 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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