# K180184: Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentalpoint AG
- Decided: Nov 16, 2018 after 297 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894595 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133255: Zeramex T and Zeramex Plus Dental Implant Systems, Dentalpoint AG (2014) Summary page 5.

## Indications for use
The ZERAMEX® XT 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® XT Dental Implant System can be used for single or multiple unit restorations. The ZERAMEX® XT Dental Implants are indicated for delayed loading. The ZERAMEX® XT dental implants are specially indicated for patients with metal allergies/intolerances and chronic illnesses due to metal allergies/intolerances. The NobelPearl 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 NobelPearl Dental Implant System can be used for single or multiple unit restorations. NobelPearl Dental Implant System are intended for delayed loading. NobelPearl Dental Implant System are specially indicated for patients with metal allergies/intolerances and chronic illness due to metal allergies/intolerances.

Source page: https://510kreport.com/device/K180184
Methodology: https://510kreport.com/methodology