Neodent Implant System – Zirconia Implant
by JJGC Indústria e Comércio de Materiais Dentários S/A. 6 variants
510(k) K210336
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210336 | Date13 Aug 2021 | 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- Withdrawn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
- DZE
- FDA applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Neodent Implant System – Zirconia Implant is a dental endosseous implant designed for osseointegration within the alveolar bone. Constructed from zirconia, this implant provides a biocompatible, metal-free alternative for restoring single-tooth or multi-tooth dental prosthetics, ensuring aesthetic integration and reduced risk of soft tissue irritation.
This system is intended for use in oral and maxillofacial surgical settings, supplied as a sterile, single-use device. It is classified under 21 CFR 872.3640 as a Class II endosseous dental implant, with FDA clearance via a 510(k) submission (K210336). Sizes and configurations are specified in the manufacturer’s technical documentation, adhering to dental implant standards for precision and biocompatibility.
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Questions
AI-generated answers, 19 Sep 2026
What makes the Neodent Implant System – Zirconia Implant different from traditional metal dental implants?
The Neodent Implant System – Zirconia Implant is designed as a metal-free alternative, constructed entirely from zirconia—a biocompatible ceramic material. This choice eliminates the risk of metal allergies or soft tissue irritation often associated with metal implants, while also providing aesthetic integration that blends seamlessly with natural teeth. The system is intended for osseointegration in the alveolar bone, supporting single-tooth or multi-tooth restorations.
Is the Neodent Implant System – Zirconia Implant meant for reuse, or is it single-use?
The Neodent Implant System – Zirconia Implant is explicitly supplied as a sterile, single-use device. This ensures patient safety and sterility, as it is intended for one-time surgical use in oral and maxillofacial procedures. Reuse is not recommended or supported by the manufacturer’s specifications.
How do I determine the correct size or configuration for a patient’s implant placement?
The available sizes and configurations for the Neodent Implant System – Zirconia Implant are detailed in the manufacturer’s technical documentation. These specifications align with dental implant standards to ensure precision and compatibility with individual patient anatomy. Clinicians should refer to the provided guidelines to select the appropriate implant dimensions for optimal osseointegration and prosthetic support.
What regulatory pathway was followed for FDA clearance of this implant system?
The Neodent Implant System – Zirconia Implant received FDA clearance through a 510(k) submission (K210336) under the Traditional Review pathway. It was classified as a Class II endosseous dental implant under 21 CFR 872.3640, with a Substantially Equivalent (SESE) determination by the Dental (DE) Advisory Committee. This process confirms its compliance with U.S. regulatory standards for dental implants.