FDA 510(k), K203641, E-Denture Pro
FDA 510(k), K203641, E-Denture Pro
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510(K) Number: K203641
Device Name: E-Denture Pro
Manufacturer: EnvisionTEC GmbH
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 12/14/2020
Decision Date: 03/30/2021
Regulation Medical Specialty: Dental
Device Name: E-Denture Pro
Manufacturer: EnvisionTEC GmbH
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 12/14/2020
Decision Date: 03/30/2021
Regulation Medical Specialty: Dental
- 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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