Cleared Traditional

TELIO CAD

K093708 · Ivoclar Vivadent, Inc. · Dental
Mar 2010
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K093708 is an FDA 510(k) clearance for the TELIO CAD, 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 March 10, 2010, 98 days after receiving the submission on December 2, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K093708 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2009
Decision Date March 10, 2010
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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