COLTENE A.R.T. BOND— 510(k) K922615

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K922615 for COLTENE A.R.T. BOND, Substantially Equivalent on 1992-08-03. 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: 1992-06-02
Decision date: 1992-08-03
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.