Z5-BL— 510(k) K200386
Substantially EquivalentZ-Systems AG
FDA 510(k) clearance K200386 for Z5-BL, Substantially Equivalent on 2020-10-14. Applicant: Z-Systems AG. Device class: 2.
Clearance details
- Applicant
- Z-Systems AG
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oensingen, CH
Recent devices under product code DZE
view allMore clearances from Z-Systems AG
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.