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FDA 510(k), K182422, Lucitone Denture Base Materials
FDA 510(k), K182422, Lucitone Denture Base Materials
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510(K) Number: K182422
Device Name: Lucitone Denture Base Materials
Manufacturer: Dentsply Sirona
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 09/06/2018
Decision Date: 12/18/2018
Regulation Medical Specialty: Dental
Device Name: Lucitone Denture Base Materials
Manufacturer: Dentsply Sirona
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 09/06/2018
Decision Date: 12/18/2018
Regulation Medical Specialty: Dental
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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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