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FDA 510(k), K212496, Ortho Aligner System
FDA 510(k), K212496, Ortho Aligner System
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$149.00 USD
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510(K) Number: K212496
Device Name: Ortho Aligner System
Manufacturer: Ortho Lab Services, LLC
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 08/09/2021
Decision Date: 11/04/2021
Regulation Medical Specialty: Dental
Device Name: Ortho Aligner System
Manufacturer: Ortho Lab Services, LLC
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 08/09/2021
Decision Date: 11/04/2021
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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