CUSTOM COMFORT NIGHTGUARD VERSION 2— 510(k) K091660

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K091660 for CUSTOM COMFORT NIGHTGUARD VERSION 2, Substantially Equivalent on 2009-06-12. Applicant: Den Tek Oral Care, Inc..

Clearance details

Applicant: Den Tek Oral Care, Inc.
Product code: Code OBR
Advisory panel: Unknown
Date received: 2009-06-09
Decision date: 2009-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

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