VENUS DIAMOND FLOW— 510(k) K091635
Substantially EquivalentHeraeus Kulzer, LLC
FDA 510(k) clearance K091635 for VENUS DIAMOND FLOW, Substantially Equivalent on 2009-09-03. Applicant: Heraeus Kulzer, LLC. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, LLC
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- South Bend, IN, US
Recent devices under product code EBF
view allMore clearances from Heraeus Kulzer, LLC
view all- K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
- K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
- K120914 — FLEXITIME FAST & SCAN LIGHT FLOW
- K113574 — FLEXITIME MONOPHASE PRO SCAN
- K112501 — VENUS PEARL PLT REFILL A1
Data sourced from openFDA. This site is unofficial and independent of the FDA.