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510(k) K253641

Owl Night Guard by Owl Dental Lab, Inc. — Product Code OBR

K253641 is an FDA 510(k) premarket notification submitted by Owl Dental Lab, Inc. for the device "Owl Night Guard". The FDA issued a decision of Substantially Equivalent on February 26, 2026. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2026
Date Received
November 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Over-The-Counter
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Other clearances for product code OBR

  • K260790 — G-Series Grind Guard (June 25, 2026)
  • K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); Clench (April 10, 2026)
  • K252004 — enCore Night Guard (November 25, 2025)
  • K251778 — Remi Custom Night Guard (October 17, 2025)
  • K250456 — Dentemp Pro-Comfort Dental Guard (May 19, 2025)
  • K240810 — Anti Grinding Guard (May 24, 2024)
  • K232238 — Goyo Mouthpiece S (April 17, 2024)
  • K231865 — Mouth Guard (ATG0603R) (November 6, 2023)
  • K221369 — FBCC Night Guard (November 18, 2022)
  • K222424 — Protect-It Custom Fit Dental Guard (October 7, 2022)

FDA data resources