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SleepRight

Splintek Inc. · Model Ultra-Comfort · UDI-DI 00692121032062

OBR
10
510(k) clearances
1,007
Adverse events
0
Recalls
36
Facilities

Description

The SleepRight Ultra-Comfort 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.