Astra Dental Implant System
by Astra Meditec AB 510(k)
Active
510(k) K882578
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882578 | Date12 Aug 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 19 Sep 2026
The Astra Dental Implant System is a dental implant device designed for osseointegrated replacement of missing teeth. It is classified as a dental implant under the FDA’s product code DZE, intended for use in oral and maxillofacial surgery to restore function and aesthetics in patients with partial or complete tooth loss.
This system is supplied as a sterile, single-use implant device, available in various sizes and configurations for different clinical applications. It is regulated under an FDA 510(k) clearance (K882578) and is manufactured by Astra Meditec AB, based in Sweden. The device is intended for use in controlled clinical settings, adhering to dental implant protocols and regulatory standards.
Other devices from Astra Meditec AB
Questions
AI-generated answers, 19 Sep 2026
What types of patients is the Astra Dental Implant System intended for in clinical practice?
The Astra Dental Implant System is designed for patients experiencing partial or complete tooth loss who require osseointegrated dental implants to restore both function and aesthetics. It is intended for use in oral and maxillofacial surgery settings, following standard dental implant protocols.
How is the Astra Dental Implant System supplied, and is it reusable?
The Astra Dental Implant System is supplied as a sterile, single-use device. This ensures patient safety and reduces the risk of cross-contamination, as each implant is intended for one-time surgical use only.
What regulatory pathway was followed for FDA clearance of this implant system?
The Astra Dental Implant System received FDA clearance through a Traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. The clearance number is K882578, and it falls under product code DZE for dental implants.
Does the system come in multiple sizes or configurations, and how might that benefit clinicians?
Yes, the Astra Dental Implant System is available in various sizes and configurations to accommodate different clinical applications. This versatility allows clinicians to select the appropriate implant for specific patient anatomy, ensuring better fit, stability, and long-term success in restoring dental function.