AXA Abutment AXARS57400
by Megagen Implant Co. Ltd EUDAMEDGUDID
Active
Ref AXARS57400C
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number8809728999036 | Date3 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08809985660375 | Date16 Aug 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- AXA Abutment
- Generic Name
- Dental implant suprastructure, permanent, preformed
- Model / Ref / Catalog
- AXARS57400C, AXARS57400
- Primary DI / UDI-DI
- 08809985660375 EUDAMED08809985659355 GUDID
- Basic UDI-DI
- 8809728999036
- 510(k) Number
- FDA Product Code
- NHA
- EMDN Code
- P01020101 Dental implants
- GMDN Term
- Dental implant suprastructure, permanent, preformed
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 872.3630
- Market of Registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | AXARS57400C | AXARS57400 |
| Primary DI / UDI-DI | 08809985660375 | 08809985659355 |
| Device Class | Class IIb | Class II |
Other devices from Megagen Implant Co., Ltd.
Properties
Other properties (18)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Expiration Date: No