Owl Night Guard— 510(k) K253641

Name: FDA 510(k) clearance K253641
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

Owl Dental Lab, Inc.

FDA 510(k) clearance K253641 for Owl Night Guard, Substantially Equivalent on 2026-02-26. Applicant: Owl Dental Lab, Inc.. Device class: Unclassified.

Clearance details

Applicant: Owl Dental Lab, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-11-19
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

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K251778 — Remi Custom Night Guard2025-10-17
K250456 — Dentemp Pro-Comfort Dental Guard2025-05-19

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