Zfx Abutments— 510(k) K231915
Substantially EquivalentZfx GmbH - A Company of Zimvie
FDA 510(k) clearance K231915 for Zfx Abutments, Substantially Equivalent on 2024-03-01. Applicant: Zfx GmbH - A Company of Zimvie. Device class: 2.
Clearance details
- Applicant
- Zfx GmbH - A Company of Zimvie
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dachau, DE
Recent devices under product code NHA
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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.