CustMBite Dental Guard— 510(k) K183315

Name: FDA 510(k) clearance K183315
Creator: U.S. Food and Drug Administration
Published: 2019-08-23

Substantially Equivalent

Dental Choice Holdings, LLC

FDA 510(k) clearance K183315 for CustMBite Dental Guard, Substantially Equivalent on 2019-08-23. Applicant: Dental Choice Holdings, LLC. Device class: Unclassified.

Clearance details

Applicant: Dental Choice Holdings, LLC
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-11-30
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, 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.