DIAFIL Bulk FLOW (3 models)— 510(k) K261071

Name: FDA 510(k) clearance K261071
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K261071 for DIAFIL Bulk FLOW (3 models), Substantially Equivalent on 2026-05-19. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Device name as filed: DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
Applicant: DiaDent Group International
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2026-04-01
Decision date: 2026-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18
K261093 — DIAFIL2026-06-02
K260805 — Dual Core2026-05-11

More clearances from DiaDent Group International

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K231552 — Dia-Cem2023-07-28
K220804 — Dia-X Bond Universal2022-06-15
K213401 — DIAPLUS Universal2022-01-31

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