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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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$49.00 USD
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$49.00 USD
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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: KXA
Date Received: 04/17/2020
Decision Date: 08/14/2020
Decision: 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: KXA
Date Received: 04/17/2020
Decision Date: 08/14/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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