DeviceClearance

SleepRight ProRx Custom Dental Guard— 510(k) K193577

Substantially Equivalent

Splintek, Inc.

FDA 510(k) clearance K193577 for SleepRight ProRx Custom Dental Guard, Substantially Equivalent on 2020-06-01. Applicant: Splintek, Inc..

Clearance details

Applicant
Splintek, Inc.
Product code
Code OBR
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lenexa, KS, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.