DiaFil Flow— 510(k) K192284

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K192284 for DiaFil Flow, Substantially Equivalent on 2020-03-25. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Applicant: DiaDent Group International
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2019-08-22
Decision date: 2020-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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

More clearances from DiaDent Group International

K261166 — DIA-CEM2026-07-09
K261093 — DIAFIL2026-06-02
K261071 — DIAFIL Bulk FLOW (3 models)2026-05-19
K254112 — Dia-X Sil Bite2026-03-19
K231552 — Dia-Cem2023-07-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.