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FDA 510(k), K201010, Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
FDA 510(k), K201010, Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
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$149.00 USD
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$149.00 USD
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per
510(K) Number: K201010
Device Name: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
Manufacturer: Galit Gershon
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: EBF
Classification Product Code: 04/17/2020
Date Received: 08/14/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite
Manufacturer: Galit Gershon
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: EBF
Classification Product Code: 04/17/2020
Date Received: 08/14/2020
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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