Cleared Traditional

IMAGINE REFLEX

K031326 · Wieland Dental + Technik GmbH & Co. KG · Dental
Jun 2003
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K031326 is an FDA 510(k) clearance for the IMAGINE REFLEX, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on June 17, 2003, 53 days after receiving the submission on April 25, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K031326 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2003
Decision Date June 17, 2003
Days to Decision 53 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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