FBCC Night Guard— 510(k) K221369

Substantially Equivalent

Fbcc, Inc.

FDA 510(k) clearance K221369 for FBCC Night Guard, Substantially Equivalent on 2022-11-18. Applicant: Fbcc, Inc.. Device class: Unclassified.

Clearance details

Applicant: Fbcc, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-05-12
Decision date: 2022-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, 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.