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FDA 510(k), K221678, SprintRay High Impact Denture Base
FDA 510(k), K221678, SprintRay High Impact Denture Base
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510(K) Number: K221678
Device Name: SprintRay High Impact Denture Base
Manufacturer: Sara Moghtadernejad
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: EBI
Classification Product Code: KXA
Date Received: 06/09/2022
Decision Date: 11/10/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: SprintRay High Impact Denture Base
Manufacturer: Sara Moghtadernejad
Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing
Regulation Number: EBI
Classification Product Code: KXA
Date Received: 06/09/2022
Decision Date: 11/10/2022
Decision: Substantially Equivalent (SESE)
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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