Neodent Zirconia Implant System
by JJGC Indústria e Comércio de Materiais Dentários S/A. 6 variants
510(k) K231803
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231803 | Date13 Dec 2023 | 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- Withdrawn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
- Full name
- Neodent Implant System - Zirconia Implant System
- 510(k) Number
- FDA Product Code
- NHA
- FDA applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Neodent Zirconia Implant System is a dental implant designed for endosseous integration within the jawbone. It features zirconia implants, a biocompatible ceramic material, intended for use in dental restoration procedures requiring durable, aesthetically pleasing, and metal-free solutions. This system is categorized under endosseous dental implants, providing a stable foundation for prosthetic teeth. Its construction prioritizes biocompatibility and long-term stability within the oral environment.
This implant system is supplied as a sterile, single-use device intended for professional dental use only. It is regulated under 21 CFR 872.3640 and classified as a Class II medical device, with FDA clearance via a 510(k) submission (K231803). The system is designed for immediate loading protocols, enabling fixed arch treatments in dental practice settings. Proper handling, storage, and adherence to manufacturer guidelines are essential to ensure sterility and clinical performance.
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Questions
AI-generated answers, 1 Oct 2026
What is the Neodent Zirconia Implant System used for?
The Neodent Zirconia Implant System is designed for dental restoration procedures requiring a stable, metal-free foundation for prosthetic teeth. Its zirconia material provides biocompatibility and aesthetic appeal, making it suitable for patients seeking durable, long-term solutions without metal components. The system is specifically engineered for endosseous integration within the jawbone, supporting fixed arch treatments.
How is the Neodent Zirconia Implant System supplied and intended for use?
The system is supplied as a sterile, single-use device exclusively for professional dental use. Sterility is maintained through controlled manufacturing processes, ensuring safety for clinical applications. It is not intended for reuse or non-professional use, as proper handling and adherence to manufacturer guidelines are critical to preserving sterility and performance.
Is the Neodent Zirconia Implant System suitable for immediate loading?
Yes, the Neodent Zirconia Implant System is explicitly designed for immediate loading protocols. This allows dental practitioners to place fixed arch prosthetics shortly after implant placement, reducing patient treatment time while maintaining stability and integration with the jawbone. Immediate loading is supported by the system’s durable zirconia construction and clinical design.
What regulatory classification and clearance does the Neodent Zirconia Implant System hold?
The Neodent Zirconia Implant System is classified as a Class II medical device under 21 CFR 872.3640 and has received FDA clearance through a 510(k) submission (K231803). This classification and clearance confirm its compliance with U.S. regulatory standards for dental implants, ensuring safety and effectiveness for professional use in dental practices.
How should the Neodent Zirconia Implant System be stored to maintain sterility?
The system must be stored in its original, unopened packaging to preserve sterility. It should be kept in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Adherence to manufacturer-provided storage instructions is essential to prevent contamination and ensure the device remains ready for immediate clinical use when required.