COLTENE AURA COMPOMER RESTORATIVE SYSTEM— 510(k) K003034

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K003034 for COLTENE AURA COMPOMER RESTORATIVE SYSTEM, Substantially Equivalent on 2000-11-30. Applicant: Coltene/Whaledent, Inc..

Clearance details

Applicant: Coltene/Whaledent, Inc.
Product code: Code EBF
Advisory panel: Dental
Date received: 2000-09-28
Decision date: 2000-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

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