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510(k) K221510

TrusFIL-Flow Flowable Composite Restorative by Rizhao Huge Biomaterials Company, Ltd. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2022
Date Received
May 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K221450 — Phosphoric Acid Etching Gel (September 12, 2022)
  • K202063 — TrusFIL Universal Composite Restorative (October 6, 2021)

Other clearances for product code EBF

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  • K251946 — G aenial Universal Injectable II (August 29, 2025)
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