Owl Night Guard— 510(k) K253641
Substantially EquivalentOwl 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.
Summary
Owl Dental Lab's Owl Night Guard is filed under product code OBR, over-the-counter mouthguard. The record doesn't describe it beyond the name and that code name.
Class U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k).
Owl Dental Lab filed from San Leandro, California. The substantially equivalent decision came 99 calendar days after receipt (November 19, 2025 to February 26, 2026).
Clearance details
- Applicant
- Owl Dental Lab, Inc.
- Product code
- Product code OBR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Leandro, CA, US
Recent devices under product code OBR
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