TrusFIL-Flow Flowable Composite Restorative— 510(k) K221510

Name: FDA 510(k) clearance K221510
Creator: U.S. Food and Drug Administration
Published: 2022-10-12

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K221510 for TrusFIL-Flow Flowable Composite Restorative, Substantially Equivalent on 2022-10-12. Applicant: Rizhao Huge Biomaterials Company, Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2022-05-24
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

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