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FDA 510(k), K211190, 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
FDA 510(k), K211190, 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
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510(K) Number: K211190
Device Name: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Manufacturer: 3M Company, Unitek Orthodontic Products
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 04/21/2021
Decision Date: 04/23/2021
Regulation Medical Specialty: Dental
Device Name: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
Manufacturer: 3M Company, Unitek Orthodontic Products
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 04/21/2021
Decision Date: 04/23/2021
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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