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FDA 510(k), K062166, ENAMEL PRO
FDA 510(k), K062166, ENAMEL PRO
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510(K) Number: K062166
Device Name: ENAMEL PRO
Manufacturer: PREMIER DENTAL PRODUCTS CO.
Device Classification Name: agent, polishing, abrasive, oral cavity
Regulation Number: 872.6030
Classification Product Code: EJR
Date Received: 07/28/2006
Decision Date: 11/21/2006
Regulation Medical Specialty: Dental
Device Name: ENAMEL PRO
Manufacturer: PREMIER DENTAL PRODUCTS CO.
Device Classification Name: agent, polishing, abrasive, oral cavity
Regulation Number: 872.6030
Classification Product Code: EJR
Date Received: 07/28/2006
Decision Date: 11/21/2006
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
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