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510(k) Submission – Ivotion Base Print (K233995, Ivoclar Vivadent, Inc.)
510(k) Submission – Ivotion Base Print (K233995, Ivoclar Vivadent, Inc.)
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510(K) Number: K233995
Device Name: Ivotion Base Print
Manufacturer: Ivoclar Vivadent, Inc
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 12/18/2023
Decision Date: 02/23/2024
Regulation Medical Specialty: Dental
Request Contents: 510(k) application (electronic PDF format) for Ivotion Base Print - K233995, submitted by Ivoclar Vivadent, Inc., including all attachments, amendments, and related correspondence.
Device Name: Ivotion Base Print
Manufacturer: Ivoclar Vivadent, Inc
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 12/18/2023
Decision Date: 02/23/2024
Regulation Medical Specialty: Dental
Request Contents: 510(k) application (electronic PDF format) for Ivotion Base Print - K233995, submitted by Ivoclar Vivadent, Inc., 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
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