# K200867: Implantswiss Dental Implant System and Implantswiss Dental Abutment System

- Pathway: 510(k) (Special)
- Applicant: Novodent SA
- Decided: Apr 28, 2020 after 27 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: 11 generations back to K944964 (1995). 143 ancestors in all.
No later device cites it as a predicate yet.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181266: Implantswiss Dental Implant System, Implantswiss Dental Abutment System, Novodent SA (2018) Summary page 4.

## Indications for use
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.

Source page: https://510kreport.com/device/K200867
Methodology: https://510kreport.com/methodology