# K160475: Ritter Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ritter Implants GmbH & Co. KG
- Decided: Dec 14, 2016 after 299 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ritter Dental Implant System is intended to replace one or more missing teeth in the upper or lower jaw in order to restore a patient’s chewing function. The abutments are used with endosseous dental implants to support a prosthetic device in a partially or edentulous patients. The Ritter Dental Implant System is intended to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. The Ritter Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K160475
Methodology: https://510kreport.com/methodology