Cleared Traditional

TELIO CS INLAY & TELIO CS ONLAY

K103379 · Ivoclar Vivadent, Inc. · Dental
Feb 2011
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K103379 is an FDA 510(k) clearance for the TELIO CS INLAY & TELIO CS ONLAY, 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 February 14, 2011, 89 days after receiving the submission on November 17, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K103379 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2010
Decision Date February 14, 2011
Days to Decision 89 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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