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FDA 510(k), K172398, DENTCA DENTURE Teeth
FDA 510(k), K172398, DENTCA DENTURE Teeth
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$149.00 USD
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510(K) Number: K172398
Device Name: DENTCA DENTURE Teeth
Manufacturer: Jason Lee
Device Classification Name: Additively Manufactured, Preformed, Resin Denture Tooth
Regulation Number: PZY
Classification Product Code: 08/08/2017
Date Received: 11/22/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: DENTCA DENTURE Teeth
Manufacturer: Jason Lee
Device Classification Name: Additively Manufactured, Preformed, Resin Denture Tooth
Regulation Number: PZY
Classification Product Code: 08/08/2017
Date Received: 11/22/2017
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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