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FDA 510(k), K181739, Invisalign System with Mandibular Advancement Feature
FDA 510(k), K181739, Invisalign System with Mandibular Advancement Feature
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510(K) Number: K181739
Device Name: Invisalign System with Mandibular Advancement Feature
Manufacturer: Align Technology, Inc.
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 07/02/2018
Decision Date: 10/26/2018
Regulation Medical Specialty: Dental
Device Name: Invisalign System with Mandibular Advancement Feature
Manufacturer: Align Technology, Inc.
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 07/02/2018
Decision Date: 10/26/2018
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
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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