Zfx Abutments
by Zfx GmbH - A Company of Zimvie 510(k)
Active
510(k) K231915
Overview
The Zfx Abutments are an endosseous dental implant abutment, classified within the NHA classification. They are a type of dental implant component. The device is substantially equivalent to other devices on the market.
The Zfx Abutments are supplied with a product code of NHA and are regulated under 21 CFR 872.3630. They have been assigned a K number, K231915, and have received FDA 510K clearance. The device is classified as a Class II device with special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231915 | Date1 Mar 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent