# K133255: Zeramex T and Zeramex Plus Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dentalpoint AG
- Decided: Aug 12, 2014 after 293 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: 3 generations back to K894595 (1990). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093595: Ceraroot Implant System, Oral Iceberg S.L. (2011) Summary page 4.
- K062542: Z-LOOK3 Dental Implant System, Model Z3-XXX, Z-Systems AG (2007) Summary page 4.
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 4.

## Most influential descendants
- K152385: Zeramex P6 Dental Implant System (2016), 1 descendant of its own
- K180184: Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant System (2018), 0 descendants of its own
- K163043: Zeramex P6 Dental Implant System (2016), 0 descendants of its own

## Indications for use
The Zeramex® T 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® T Dental Implant System can be used for single or multiple unit restorations. Zeramex® T implants are intended for delayed loading. The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies. The Zeramex® T (Ø 3.5 mm) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

Source page: https://510kreport.com/device/K133255
Methodology: https://510kreport.com/methodology