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FDA 510(k), K212706, SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
FDA 510(k), K212706, SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
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/
per
510(K) Number: K212706
Device Name: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Manufacturer: Splintek, Inc.
Device Classification Name: Mouthguard, Over-The-Counter
Regulation Number:
Classification Product Code: OBR
Date Received: 08/26/2021
Decision Date: 12/13/2021
Regulation Medical Specialty:
Device Name: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Manufacturer: Splintek, Inc.
Device Classification Name: Mouthguard, Over-The-Counter
Regulation Number:
Classification Product Code: OBR
Date Received: 08/26/2021
Decision Date: 12/13/2021
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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