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.

Summary

DiaDent Group International's record lists DIAFIL Bulk FLOW in three packages: Economic Package, Refill Package, and 0.5g. The product code is EBF, tooth shade resin materials.

Class II, 21 CFR 872.3690. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).

DiaDent filed from Cheongju-Si, South Korea. Review took 48 calendar days (April 1 to May 19, 2026).

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: Product 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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K262982 — Core·it Dual2026-09-21
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

More clearances from DiaDent Group International

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K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K261166 — DIA-CEM2026-07-09
K261093 — DIAFIL2026-06-02
K254112 — Dia-X Sil Bite2026-03-19

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