ONE COAT SE BOND— 510(k) K033760

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K033760 for ONE COAT SE BOND, Substantially Equivalent on 2004-01-23. Applicant: Coltene/Whaledent, Inc.. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2003-12-02
Decision date: 2004-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.