Cleared Abbreviated

Accu-Dent XD Tray, Accu-Dent XD Syringe

K143575 · Ivoclar Vivadent, Inc. · Dental
Apr 2015
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K143575 is an FDA 510(k) clearance for the Accu-Dent XD Tray, Accu-Dent XD Syringe, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on April 3, 2015, 107 days after receiving the submission on December 17, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K143575 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2014
Decision Date April 03, 2015
Days to Decision 107 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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