FDA 510(k), K180241, Orthocaps Twinaligner
FDA 510(k), K180241, Orthocaps Twinaligner
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510(K) Number: K180241
Device Name: Orthocaps Twinaligner
Manufacturer: Ortho Caps GmbH
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 01/29/2018
Decision Date: 09/28/2018
Regulation Medical Specialty: Dental
Device Name: Orthocaps Twinaligner
Manufacturer: Ortho Caps GmbH
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 01/29/2018
Decision Date: 09/28/2018
Regulation Medical Specialty: Dental
- 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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