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FDA 510(k), K151965, Dentti System
FDA 510(k), K151965, Dentti System
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510(K) Number: K151965
Device Name: Dentti System
Manufacturer: Andrew Martz
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: 07/16/2015
Date Received: 03/11/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Dentti System
Manufacturer: Andrew Martz
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: 07/16/2015
Date Received: 03/11/2016
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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