# K202269: PRE-MILLED Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Mit Global Co., Ltd.
- Decided: Nov 25, 2020 after 106 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: 14 generations back to K894844 (1990). 171 ancestors in all.
No later device cites it as a predicate yet.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 4.

## Indications for use
The PRE-MILLED Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. It is compatible with the following systems: • Zimmer 3.1mmD Dental Implant System (K142082) • Screw Vent® and Tapered Screw Vent® (K013227) All digitally designed abutments for use with the PRE-MILLED Abutments must be designed and milled through the 3Shape CAD/CAM System and are intended to be sent to a validated milling center for manufacture. The PRE-MILLED Abutment is compatible with the following devices: Zimmer 3.1mmD Dental Implant System (K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex

Source page: https://510kreport.com/device/K202269
Methodology: https://510kreport.com/methodology