Ora-GUARD Dental Grind Guard— 510(k) K150492

Name: FDA 510(k) clearance K150492
Creator: U.S. Food and Drug Administration
Published: 2016-02-19

Substantially Equivalent

Bite Tech, Inc.

FDA 510(k) clearance K150492 for Ora-GUARD Dental Grind Guard, Substantially Equivalent on 2016-02-19. Applicant: Bite Tech, Inc.. Device class: Unclassified.

Clearance details

Applicant: Bite Tech, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2015-02-25
Decision date: 2016-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, 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.