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FDA 510(k), K193659, iTero Element 5D
FDA 510(k), K193659, iTero Element 5D
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$149.00 USD
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510(K) Number: K193659
Device Name: iTero Element 5D
Manufacturer: Align Technology, Inc.
Device Classification Name: Caries Detector, Laser Light, Transmission
Regulation Number: 872.1745
Classification Product Code: NTK
Date Received: 12/30/2019
Decision Date: 03/20/2020
Regulation Medical Specialty: Dental
Device Name: iTero Element 5D
Manufacturer: Align Technology, Inc.
Device Classification Name: Caries Detector, Laser Light, Transmission
Regulation Number: 872.1745
Classification Product Code: NTK
Date Received: 12/30/2019
Decision Date: 03/20/2020
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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