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FDA 510(k), K113040, CERAMIR CROWN & BRIDGE
FDA 510(k), K113040, CERAMIR CROWN & BRIDGE
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510(K) Number: K113040
Device Name: CERAMIR CROWN & BRIDGE
Manufacturer: MARGARETH JORVID
Device Classification Name: Cement, Dental
Regulation Number: EMA
Classification Product Code: KXA
Date Received: 10/12/2011
Decision Date: 12/28/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: CERAMIR CROWN & BRIDGE
Manufacturer: MARGARETH JORVID
Device Classification Name: Cement, Dental
Regulation Number: EMA
Classification Product Code: KXA
Date Received: 10/12/2011
Decision Date: 12/28/2011
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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