Neodent Implant System Custom Abutments
by Jjgc Indústria E Comércia DE Materiais Dentários S.A.
510(k) K250614
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250614 | Date27 May 2025 | 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- Withdrawn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
- NHA
- 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 Implant System Custom Abutments is classified as a dental abutment, designed to connect dental implants to prosthetic crowns, bridges, or dentures. These abutments are tailored to individual patient anatomy, ensuring precise fit and stability for implant-supported restorations. Manufactured from biocompatible materials, they are engineered to integrate seamlessly with Neodent’s implant system, facilitating predictable outcomes in implant dentistry. Their custom design allows for optimal alignment and occlusion, enhancing long-term success of the prosthetic restoration.
These custom abutments are supplied as part of the Neodent Implant System and are intended for use in dental offices by trained professionals. They are sterilized and packaged for single-use, adhering to dental implant protocols. The product is regulated under the FDA’s 510(k) clearance (K250614) as a dental device, with no specific MRI safety restrictions noted. Sizes and configurations are determined by the patient’s anatomical requirements and are selected based on the implant platform. Storage instructions specify a clean, dry environment away from direct sunlight, and the device is authorized for use in the United States.
Other devices from Jjgc Indústria E Comércia DE Materiais Dentários S.A.
Questions
AI-generated answers, 1 Oct 2026
What is the Neodent Custom Abutments system used for?
The Neodent Custom Abutments are designed to connect dental implants to prosthetic crowns, bridges, or dentures. Their custom fit ensures precise alignment and stability, which is critical for the long-term success of implant-supported restorations. The abutments integrate specifically with Neodent’s implant system to provide predictable outcomes in dental implantology.
How are the Neodent Custom Abutments supplied and intended for use?
These abutments are supplied as part of the Neodent Implant System and are intended exclusively for use in dental offices by trained dental professionals. They come pre-sterilized and packaged for single-use, adhering to standard dental implant protocols to maintain sterility and safety.
Are the Neodent Custom Abutments reusable or single-use?
The Neodent Custom Abutments are designed for single-use only. This ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices in dental implantology. Each abutment is individually packaged and sterilized for one-time clinical application.
How are the sizes and configurations of the Neodent Custom Abutments determined?
The sizes and configurations of the Neodent Custom Abutments are tailored to match each patient’s unique anatomical requirements. They are selected based on the specific implant platform used in the patient’s procedure, ensuring optimal fit, alignment, and occlusion for the prosthetic restoration.
What storage conditions are recommended for the Neodent Custom Abutments?
The Neodent Custom Abutments should be stored in a clean, dry environment away from direct sunlight. Proper storage helps preserve the integrity of the abutments and ensures they remain ready for use when needed in clinical settings.