SOUTH BEACH SMILE LIGHT WHITENING SYSTEM— 510(k) K042153

Name: FDA 510(k) clearance K042153
Creator: U.S. Food and Drug Administration
Published: 2004-11-08

Substantially Equivalent

Dentovations, Inc.

FDA 510(k) clearance K042153 for SOUTH BEACH SMILE LIGHT WHITENING SYSTEM, Substantially Equivalent on 2004-11-08. Applicant: Dentovations, Inc.. Device class: 1.

Clearance details

Applicant: Dentovations, Inc.
Product code: Code EEG
Device class: Class 1
Regulation: 21 CFR 872.6475
Advisory panel: Dental
Date received: 2004-08-09
Decision date: 2004-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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