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510(k) Submission – NextDent Base (K231388, Vertex-Dental B.V.)
510(k) Submission – NextDent Base (K231388, Vertex-Dental B.V.)
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510(K) Number: K231388
Device Name: NextDent Base
Manufacturer: Vertex-Dental B.V.
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 05/12/2023
Decision Date: 10/20/2023
Regulation Medical Specialty: Dental
Request Contents: 510(k) application (electronic PDF format) for NextDent Base - K231388, submitted by Vertex-Dental B.V., including all attachments, amendments, and related correspondence.
Device Name: NextDent Base
Manufacturer: Vertex-Dental B.V.
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 05/12/2023
Decision Date: 10/20/2023
Regulation Medical Specialty: Dental
Request Contents: 510(k) application (electronic PDF format) for NextDent Base - K231388, submitted by Vertex-Dental B.V., including all attachments, amendments, and related correspondence.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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