Ankylos C/X Dental Implant System
510(k) K083805
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083805 | Date22 May 2009 | 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- Withdrawn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 Ankylos C/X Dental Implant System is a dental implant designed for osseointegration in the jawbone to support single-stage or two-stage surgical procedures. It provides a foundation for cemented, removable, or screw-retained restorations, featuring a tapered TissueCare connection for improved stability. The system is categorized under dental implants and is intended for use in reconstructive oral and maxillofacial applications. Four implant diameters (A, B, C, D) accommodate varying patient anatomies and clinical needs.
This system is supplied sterile and intended for single-use, requiring surgical placement by a trained dental professional. It is not MRI-safe and must be handled with sterile techniques during implantation. Storage should follow manufacturer guidelines to maintain sterility and integrity. The device holds an FDA 510(k) clearance under the Traditional review pathway, classified under product code DZE for dental implants.
Other devices from Dentsply Intl.
Questions
AI-generated answers, 1 Oct 2026
What is the Ankylos C/X Dental Implant System used for?
The Ankylos C/X Dental Implant System is designed for osseointegration in the jawbone to serve as a foundation for dental restorations. It supports both single-stage and two-stage surgical procedures, accommodating cemented, removable, or screw-retained prosthetics in reconstructive oral and maxillofacial applications. Its tapered TissueCare connection enhances stability during placement.
How is the Ankylos C/X Dental Implant System supplied and prepared for use?
The system is supplied sterile and intended for single-use only. It must be handled using sterile techniques during surgical placement by a trained dental professional to ensure patient safety and device integrity. Follow the manufacturer’s guidelines for unpacking and preparation to maintain sterility.
Are there different sizes or models available in this implant system?
Yes, the Ankylos C/X system includes four implant diameters labeled A, B, C, and D. These variations accommodate different patient anatomies and clinical requirements, allowing for customized treatment planning based on individual needs.
Can the Ankylos C/X Dental Implant System be reused?
No, the Ankylos C/X Dental Implant System is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, and patient safety.
How should the Ankylos C/X Dental Implant System be stored?
Storage must adhere to the manufacturer’s guidelines to preserve sterility and device integrity. The packaging should remain unopened until immediate use, and the system should be stored in a clean, dry environment away from direct sunlight or extreme temperatures.