SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard— 510(k) K212706

Name: FDA 510(k) clearance K212706
Creator: U.S. Food and Drug Administration
Published: 2021-12-13

Substantially Equivalent

Splintek, Inc.

FDA 510(k) clearance K212706 for SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard, Substantially Equivalent on 2021-12-13. Applicant: Splintek, Inc.. Device class: Unclassified.

Clearance details

Applicant: Splintek, Inc.
Product code: Code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-08-26
Decision date: 2021-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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