GRADIA DIRECT X— 510(k) K070190

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K070190 for GRADIA DIRECT X, Substantially Equivalent on 2007-03-12. Applicant: GC America, Inc..

Clearance details

Applicant: GC America, Inc.
Product code: Code EBF
Advisory panel: Dental
Date received: 2007-01-22
Decision date: 2007-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

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