Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One— 510(k) K260783
Substantially EquivalentKulzer, 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.
Summary
Kulzer's record covers four products: Venus Diamond, Venus Diamond Flow, Venus Pearl and Venus Bulk Flow One. They're filed under EBF, resin tooth shade materials.
Class II, 21 CFR 872.3690. It was a Traditional 510(k), and Dental is both the classification panel and the review panel.
Kulzer filed from South Bend, Indiana. The decision came 1 calendar day after FDA received it (March 10 to March 11, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Kulzer, LLC
- Product code
- Product code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Bend, IN, US
Recent devices under product code EBF
view allMore clearances from Kulzer, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.