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510(k) K252004

enCore Night Guard by Encore Guards — Product Code OBR

K252004 is an FDA 510(k) premarket notification submitted by Encore Guards for the device "enCore Night Guard". The FDA issued a decision of Substantially Equivalent on November 25, 2025. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device. Encore Guards has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2025
Date Received
June 27, 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 by Encore Guards

  • K251926 — enCore Impression Material (March 17, 2026)

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)
  • K253641 — Owl Night Guard (February 26, 2026)
  • 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