SDC-IPR G5-ProLign Starter Kit COXO
Ref 1300-KIT-COXO-C3-11Model SDC-KIT
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764035775_SDC-KIT_VG 07640357750987 | Date21 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Swissdentacare IPR Kit with handpiece
- Model / Reference
- SDC-KIT, 1300-KIT-COXO-C3-11
- Primary DI / UDI-DI
- 07640357750987
- Basic UDI-DI
- 764035775_SDC-KIT_VG
- EMDN Code
- Q01010199, Q010499
- Device Class
- Class IIa
- Medical Purpose
- System placed on the market under Article 22 MDR, combining CE-marked Swissdentacare oscillating instruments (Class IIa) with a CE-marked oscillating contra-angle handpiece of another manufacturer, for interproximal enamel reduction, contouring and finishing in orthodontic treatments and dental restoration, used by dental professionals.
Manufacturer details
- EUDAMED SRN
- CH-PR-000060212
Other devices from Swissdentacare SA
Properties
Other properties (1)
- Sterile: No