SleepRight Select-Comfort Dental Guard

Mouthguard, Prescription

Splintek, Inc.

The following data is part of a premarket notification filed by Splintek, Inc. with the FDA for Sleepright Select-comfort Dental Guard.

Pre-market Notification Details

Device IDK212767
510k NumberK212767
Device Name:SleepRight Select-Comfort Dental Guard
ClassificationMouthguard, Prescription
Applicant Splintek, Inc. 15555 West 108th Street Lenexa,  KS  66219
ContactThomas W. Brown
CorrespondentThomas W. Brown
Splintek, Inc. 15555 West 108th Street Lenexa,  KS  66219
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-31
Decision Date2021-12-22

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