MyPlant II Implant System
by Hager& Meisinger GmbH EUDAMED510(k)
Active
510(k) K173819
Overview
The MyPlant II Implant System is a dental implant device designed for osseointegrated fixation in the jawbone, intended for use in dental restoration procedures. It is classified as a dental implant system, featuring components for anchoring and supporting prosthetic teeth or dental structures within the oral cavity.
This system is supplied as a sterile, single-use implant kit and is intended for use in clinical dental settings by trained professionals. It is authorised under FDA 510K and MDR regulations, with a product code of DZE. The system includes all necessary components for surgical placement, adhering to strict sterility and handling protocols to ensure safe and effective dental implant procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK173819 | Date9 Aug 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hager& Meisinger GmbH
Questions
What types of dental procedures is the MyPlant II Implant System intended for, and who should perform them?
The MyPlant II Implant System is designed specifically for osseointegrated dental implant procedures in the jawbone, where it anchors and supports prosthetic teeth or dental structures. It is intended for use in clinical dental settings by trained dental professionals, such as oral surgeons or implantologists, who have the expertise to perform surgical placements.
Is the MyPlant II Implant System single-use or reusable, and what sterility precautions should be taken?
The MyPlant II Implant System is supplied as a sterile, single-use kit, meaning each component is intended for one surgical procedure only. This design ensures patient safety by minimizing the risk of infection. Strict adherence to the provided sterility and handling protocols is required to maintain its sterile condition before use.
How is the MyPlant II Implant System authorized for use, and what regulatory pathways does it follow?
The MyPlant II Implant System is authorized under both FDA 510K and MDR (Medical Device Regulation) pathways. It was determined to be substantially equivalent to a predicate device under the FDA’s traditional 510(k) process, with a product code classification of DZE. This means it meets the regulatory standards for dental implant systems in both the U.S. and EU markets.
What components does the MyPlant II Implant System include, and how is it packaged for clinical use?
The MyPlant II Implant System is supplied as a complete kit containing all necessary components for surgical placement of dental implants, including the implant fixtures and any required anchoring or abutment parts. The kit is sterile and packaged specifically for single-use in clinical settings, ensuring ease of use and compliance with infection control protocols.
Where can I find more information about the manufacturer or contact details for technical support?
For manufacturer details, the MyPlant II Implant System is produced by Hager& Meisinger GmbH, located at Hansemannstrasse 10, 41468 Neuss, Germany. For technical inquiries or support, you can reach out to Adam Tomczak, who serves as the contact person for the company.