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FDA 510(k), K191103, Parkell Desensitizer Gel
FDA 510(k), K191103, Parkell Desensitizer Gel
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$149.00 USD
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$149.00 USD
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510(K) Number: K191103
Device Name: Parkell Desensitizer Gel
Manufacturer: David Mott
Device Classification Name: Liner, Cavity, Calcium Hydroxide
Regulation Number: EJK
Classification Product Code: 04/25/2019
Date Received: 11/22/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Parkell Desensitizer Gel
Manufacturer: David Mott
Device Classification Name: Liner, Cavity, Calcium Hydroxide
Regulation Number: EJK
Classification Product Code: 04/25/2019
Date Received: 11/22/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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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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