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FDA 510(k), K122467, 3M TRUE DEFINITION SCANNER
FDA 510(k), K122467, 3M TRUE DEFINITION SCANNER
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510(K) Number: K122467
Device Name: 3M TRUE DEFINITION SCANNER
Manufacturer: GINGER CANTOR
Device Classification Name: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Regulation Number: NOF
Classification Product Code: KXA
Date Received: 08/13/2012
Decision Date: 11/20/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: 3M TRUE DEFINITION SCANNER
Manufacturer: GINGER CANTOR
Device Classification Name: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Regulation Number: NOF
Classification Product Code: KXA
Date Received: 08/13/2012
Decision Date: 11/20/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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