NEW COMFORT-FIT DENTAL GUARD— 510(k) K123849

Name: FDA 510(k) clearance K123849
Creator: U.S. Food and Drug Administration
Published: 2013-01-10

Substantially Equivalent

Den Tek Oral Care, Inc.

FDA 510(k) clearance K123849 for NEW COMFORT-FIT DENTAL GUARD, Substantially Equivalent on 2013-01-10. Applicant: Den Tek Oral Care, Inc.. Device class: Unclassified.

Clearance details

Applicant: Den Tek Oral Care, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-12-14
Decision date: 2013-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Maryville, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.