OPAL SEAL— 510(k) K090355

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K090355 for OPAL SEAL, Substantially Equivalent on 2009-04-29. Applicant: Ultradent Products, Inc..

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code DYH
Advisory panel: Dental
Date received: 2009-02-11
Decision date: 2009-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

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