510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212706Substantially Equivalent

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

Splintek Inc., Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212706 is the FDA 510(k) clearance record for SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard, cleared for Splintek, Inc. on under FDA product code OBR (Mouthguard, Over-The-Counter). FDA's definition for product code OBR reads: "To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding". FDA records list 5 510(k) clearances for Splintek, Inc., from to . As of , FDA records show no recalls naming K212706.

Clearance record

Decision date
Received
(109 days to decision)
Product code
OBR Mouthguard, Over-The-Counter
Device class
Unclassified
Review panel
Unknown
Applicant
Splintek, Inc. 15555 W. 108th St., Lenexa KS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBR

Trailing 12 months
5 clearances under product code OBR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OBR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260