Cleared Traditional

SR PHONARES NHC

K093331 · Ivoclar Vivadent, Inc. · Dental
Jan 2010
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K093331 is an FDA 510(k) clearance for the SR PHONARES NHC, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on January 28, 2010, 94 days after receiving the submission on October 26, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number K093331 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2009
Decision Date January 28, 2010
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELM — Denture, Plastic, Teeth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3590

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