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FDA 510(k), K121685, SOPROCARE
FDA 510(k), K121685, SOPROCARE
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510(K) Number: K121685
Device Name: SOPROCARE
Manufacturer: RICK ROSATI
Device Classification Name: Laser, Fluorescence Caries Detection
Regulation Number: NBL
Classification Product Code: 06/07/2012
Date Received: 03/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: SOPROCARE
Manufacturer: RICK ROSATI
Device Classification Name: Laser, Fluorescence Caries Detection
Regulation Number: NBL
Classification Product Code: 06/07/2012
Date Received: 03/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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