TEMPBOND CLEAR WITH TRICLOSAN— 510(k) K053565

Name: FDA 510(k) clearance K053565
Creator: U.S. Food and Drug Administration
Published: 2006-02-03

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K053565 for TEMPBOND CLEAR WITH TRICLOSAN, Substantially Equivalent on 2006-02-03. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2005-12-22
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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