Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One— 510(k) K260783

Name: FDA 510(k) clearance K260783
Creator: U.S. Food and Drug Administration
Published: 2026-03-11

Substantially Equivalent

Kulzer, LLC

FDA 510(k) clearance K260783 for Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One, Substantially Equivalent on 2026-03-11. Applicant: Kulzer, LLC. Device class: 2.

Clearance details

Applicant: Kulzer, LLC
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2026-03-10
Decision date: 2026-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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