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FDA 510(k), K203737, Spark Clear Aligner System
FDA 510(k), K203737, Spark Clear Aligner System
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$149.00 USD
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510(K) Number: K203737
Device Name: Spark Clear Aligner System
Manufacturer: Ormco Corporation
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/22/2020
Decision Date: 03/22/2021
Regulation Medical Specialty: Dental
Device Name: Spark Clear Aligner System
Manufacturer: Ormco Corporation
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/22/2020
Decision Date: 03/22/2021
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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