Cleared Traditional

IVOBASE HYBRID, IVOBASE HIGH IMPACT

K103391 · Ivoclar Vivadent, Inc. · Dental
Feb 2011
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K103391 is an FDA 510(k) clearance for the IVOBASE HYBRID, IVOBASE HIGH IMPACT, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on February 17, 2011, 90 days after receiving the submission on November 19, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K103391 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2010
Decision Date February 17, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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