FDA 510(k) clearance · back to tracker

DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

DiaDent Group International cleared K261071 on 2026-05-19, decision: substantially equivalent

K-number

K261071

Sponsor

DiaDent Group International

Device

DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-19

Product code

EBF

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.3690

Official FDA record

Open K261071on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.