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FDA 510(k), K212767, SleepRight Select-Comfort Dental Guard
FDA 510(k), K212767, SleepRight Select-Comfort Dental Guard
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$89.00 USD
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510(K) Number: K212767
Device Name: SleepRight Select-Comfort Dental Guard
Manufacturer: Splintek, Inc.
Device Classification Name: Mouthguard, Prescription
Regulation Number:
Classification Product Code: MQC
Date Received: 08/31/2021
Decision Date: 12/22/2021
Regulation Medical Specialty:
Device Name: SleepRight Select-Comfort Dental Guard
Manufacturer: Splintek, Inc.
Device Classification Name: Mouthguard, Prescription
Regulation Number:
Classification Product Code: MQC
Date Received: 08/31/2021
Decision Date: 12/22/2021
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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