# K163043: Zeramex P6 Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Dentalpoint AG
- Decided: Nov 30, 2016 after 30 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894595 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152385: Zeramex P6 Dental Implant System, Dentalpoint AG (2016) Summary page 4.

## Indications for use
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations. The Zeramex® P6 implants are intended for delayed loading. The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances. The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw.

Source page: https://510kreport.com/device/K163043
Methodology: https://510kreport.com/methodology