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Splintek, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories3
Latest FDA decision2025-05-19
TypeNumberDevice NameCodeDateActions
510(k) K250122 SleepRight Snore AidLRK2025-05-19 View
510(k) K212767 SleepRight Select-Comfort Dental GuardMQC2021-12-22 View
510(k) K212706 SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardOBR2021-12-13 View
510(k) K193577 SleepRight ProRx Custom Dental GuardOBR2020-06-01 View
510(k) K172223 SleepRight ProRx Custom Dental GuardOBR2017-11-17 View
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