DeviceClearance

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM— 510(k) K974906

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K974906 for ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM, Substantially Equivalent on 1998-03-24. Applicant: Coltene/Whaledent, Inc..

Clearance details

Applicant
Coltene/Whaledent, Inc.
Product code
Code KLE
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mahwah, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.