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510(k) K172223

SleepRight ProRx Custom Dental Guard by Splintek, Inc. — Product Code OBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2017
Date Received
July 24, 2017
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 Splintek, Inc.

  • K250122 — SleepRight Snore Aid (May 19, 2025)
  • K212767 — SleepRight Select-Comfort Dental Guard (December 22, 2021)
  • K212706 — SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (December 13, 2021)
  • K193577 — SleepRight ProRx Custom Dental Guard (June 1, 2020)

Other clearances for product code OBR

  • K253641 — Owl Night Guard (February 26, 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)
  • K212706 — SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (December 13, 2021)