CUSTOM COMFORT NIGHTGUARD— 510(k) K083400

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K083400 for CUSTOM COMFORT NIGHTGUARD, Substantially Equivalent on 2008-12-11. Applicant: Den Tek Oral Care, Inc..

Clearance details

Applicant: Den Tek Oral Care, Inc.
Product code: Code OBR
Advisory panel: Unknown
Date received: 2008-11-17
Decision date: 2008-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

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