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SleepRight

Splintek Inc. · Model ProRx · UDI-DI 00692121035216

OBR
10
510(k) clearances
1,006
Adverse events
0
Recalls
36
Facilities

Description

SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.