Cleared Traditional

TelioCAD Multi

K153753 · Ivoclar Vivadent, Inc. · Dental
Apr 2016
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K153753 is an FDA 510(k) clearance for the TelioCAD Multi, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on April 12, 2016, 105 days after receiving the submission on December 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K153753 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2015
Decision Date April 12, 2016
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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