Neodent Implant System
by Jjgc Industria E Comercio DE Materiais Dentarios S 8 variants
510(k) K123022
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123022 | Date17 May 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Neodent Implant System is a dental implant device designed for osseointegrated replacement of missing teeth. It is classified under dental implant systems, providing a foundation for fixed prostheses such as crowns, bridges, or dentures. Constructed to facilitate predictable integration with bone tissue, it supports long-term stability and functionality in oral rehabilitation. The system is intended for use in surgical procedures where natural tooth roots are replaced to restore chewing efficiency and aesthetic appearance.
This implant system is supplied sterile and intended for single-use in controlled clinical settings by dental professionals. It is regulated under 21 CFR 872.3630 and classified as a Class II medical device, with an FDA 510(k) clearance (K123022) under the Dental (DE) advisory committee. The system is available in various sizes and configurations to accommodate different patient anatomies, ensuring customizable placement for optimal outcomes. Storage and handling must comply with sterile medical device protocols to maintain integrity before use.
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Questions
AI-generated answers, 1 Oct 2026
What is the Neodent Implant System used for?
The Neodent Implant System is designed to replace missing natural teeth by providing a stable foundation for fixed prosthetics, such as crowns, bridges, or dentures. It is specifically engineered for osseointegration—where the implant integrates with bone tissue—to restore chewing function and aesthetic appearance in dental rehabilitation.
Is the Neodent Implant System sterile and single-use?
Yes, the Neodent Implant System is supplied sterile and intended for single-use only in controlled clinical settings. This ensures patient safety and maintains the integrity of the implant before surgical use, adhering to strict sterile medical device protocols.
How are the implants sized and configured?
The system offers various sizes and configurations to match different patient anatomies, allowing for customizable placement. This adaptability helps optimize stability and long-term success in oral rehabilitation by accommodating individual dental structures.
What regulatory approval does the Neodent Implant System hold?
The Neodent Implant System holds FDA 510(k) clearance (K123022) under the Dental (DE) advisory committee, classified as a Class II medical device. It is regulated under 21 CFR 872.3630 and is substantially equivalent to predicate devices, ensuring compliance with U.S. medical device standards.
How should the Neodent Implant System be stored before use?
The system must be stored according to sterile medical device protocols to preserve its integrity. Proper storage conditions prevent contamination and ensure the implant remains ready for surgical use when needed, maintaining its sterile state until deployment.