Neodent GM Zygomatic Implant System
by JJGC Indústria e Comércio de Materiais Dentários S/A.
510(k) K232099
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK232099 | Date31 Oct 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Neodent Implant System - GM Zygomatic Implant System
- 510(k) Number
- FDA Product Code
- DZE
- FDA applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Neodent GM Zygomatic Implant System is a dental implant designed for use in the zygomatic bone, classified as an endosseous dental implant under 21 CFR 872.3640. It is intended for patients with severe posterior maxilla resorption where conventional implant placement is not feasible, providing an alternative to bone grafting procedures for full-arch restoration.
This system is supplied as a sterile, single-use implant with a Grand Morse connection, enabling immediate loading protocols in fixed prosthodontics. It is regulated under FDA 510(k) clearance (K232099) and the EU Medical Device Regulation (MDR), with specifications reviewed by the Dental (DE) Advisory Committee. Storage and handling must adhere to sterile medical device protocols to ensure clinical safety.
Other devices from JJGC Indústria e Comércio de Materiais Dentários S/A.
See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →
Questions
AI-generated answers, 18 Sep 2026
What specific type of patient is the Neodent GM Zygomatic Implant System intended for, and why is it an alternative to traditional bone grafting?
The Neodent GM Zygomatic Implant System is designed for patients with severe bone resorption in the posterior maxilla, where conventional dental implants cannot be placed due to insufficient bone volume. It serves as an alternative to bone grafting by anchoring directly into the zygomatic bone, enabling full-arch restoration without the need for additional grafting procedures.
Is the Neodent GM Zygomatic Implant System meant for immediate loading, and what does that mean for the patient?
Yes, the system is designed for immediate loading protocols, meaning it can support a fixed prosthesis right after placement. This allows patients to receive a functional restoration sooner, reducing the time between surgery and having a stable, functional dental arch.
How is the Neodent GM Zygomatic Implant System supplied, and what precautions should be taken during storage?
The implant is supplied as a sterile, single-use device, ensuring clinical safety and preventing cross-contamination. Storage must follow sterile medical device protocols to maintain its integrity, as improper handling could compromise its sterility and performance.
What type of connection does the Neodent GM Zygomatic Implant System use, and how does this affect its compatibility with prosthodontics?
The system features a Grand Morse connection, which provides a secure and standardized interface for attaching prosthetic components. This connection type is designed to ensure stability and reliability in fixed prosthodontics, facilitating easier and more predictable restoration procedures.
What regulatory pathways has the Neodent GM Zygomatic Implant System undergone, and which advisory committee was involved in its review?
The system has received FDA 510(k) clearance (K232099) and complies with the EU Medical Device Regulation (MDR). Its review was conducted by the FDA’s Dental (DE) Advisory Committee, which evaluates dental implant submissions under 21 CFR 872.3640.