Cleared Traditional

SR PHONARES II

K120736 · Ivoclar Vivadent, AG · Dental
May 2012
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K120736 is an FDA 510(k) clearance for the SR PHONARES II, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on May 14, 2012, 66 days after receiving the submission on March 9, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number K120736 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2012
Decision Date May 14, 2012
Days to Decision 66 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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