K3Pro Implant/abutment screws
by Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG 15 variants
Ref ETS.K3PRO/3Model Abutment Screw K3Pro 3mm
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-EAGNETSK3PRO30 EAGNETSK3PRO30 | Date17 Sep 2024 | StatusActive |
| United States | GUDID listing GUDID | NumberEAGNETSK3PRO30 | Date16 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- K3Pro Implant/abutment screws EUDAMEDK3Pro Konus Dental Implants GUDID
- Generic Name
- Dental prosthesis/implant abutment screw
- Model / Ref / Catalog
- Abutment Screw K3Pro 3mm, ETS.K3PRO/3
- Primary DI / UDI-DI
- EAGNETSK3PRO30
- Basic UDI-DI
- B-EAGNETSK3PRO30
- 510(k) Number
- FDA Product Code
- NDP
- EMDN Code
- P01020101 Dental implants
- GMDN Term
- Dental prosthesis/implant abutment screw
- Device Class
- Class IIb EUDAMEDClass I GUDID
- Regulation Number
- 872.3980
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class I |
| Implantable | No | Yes |
Manufacturer details
- EUDAMED SRN
- DE-MF-000012472
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Properties
Other properties (18)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: 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
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No