Cleared Traditional

BLUEPHASE STYLE

K110756 · Ivoclar Vivadent, Inc. · Dental
Aug 2011
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K110756 is an FDA 510(k) clearance for the BLUEPHASE STYLE, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on August 29, 2011, 164 days after receiving the submission on March 18, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K110756 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2011
Decision Date August 29, 2011
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

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