• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K151909, Noris Medical Zygomatic Dental Implant System, by Noris Medical , Ltd.

FDA 510(k) K151909, Noris Medical Zygomatic Dental Implant System, by Noris Medical , Ltd.

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510(K) Number: K151909
Device Name: Noris Medical Zygomatic Dental Implant System
Manufacturer: Noris Medical , Ltd.
Device Classification Name: implant, endosseous, root-form
Regulation Number: 872.3640
Classification Product Code: DZE
Date Received: 07/13/2015
Decision Date: 04/08/2016
Regulation Medical Specialty: Dental

577 pages (931 of 1,508 original pages are fully redacted)
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