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FDA 510(k), K083400, CUSTOM COMFORT NIGHTGUARD
FDA 510(k), K083400, CUSTOM COMFORT NIGHTGUARD
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$149.00 USD
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510(K) Number: K083400
Device Name: CUSTOM COMFORT NIGHTGUARD
Manufacturer: DENTEK ORAL CARE, INC.
Device Classification Name: mouthguard, over-the-counter
Regulation Number:
Classification Product Code: OBR
Date Received: 11/17/2008
Decision Date: 12/11/2008
Regulation Medical Specialty:
Device Name: CUSTOM COMFORT NIGHTGUARD
Manufacturer: DENTEK ORAL CARE, INC.
Device Classification Name: mouthguard, over-the-counter
Regulation Number:
Classification Product Code: OBR
Date Received: 11/17/2008
Decision Date: 12/11/2008
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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