Zygomatic implant
Ref 133IR37BModel ZYGOMAX, ZYGO-ROUND, ZYGO-FLAT
Active
CE MDR
Valid until
20 Dec 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number007-00-06-MDR | Date27 Apr 2026 | StatusActive |
Certificates
- 007-00-06-MDR Active
Quality management system EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 27 Apr 2026
- Expires
- 20 Dec 2027
- Reason
- Add device or group
- 008-00-04-MDR Active
Technical documentation EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 5 Mar 2026
- Expires
- 20 Dec 2027
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Zygomatic implant
- Model / Reference
- ZYGOMAX, ZYGO-ROUND, ZYGO-FLAT, 133IR37B
- Primary DI / UDI-DI
- +D748133IR37B0H
- Basic UDI-DI
- ++D748ZYGRHIMPLSWM
- EMDN Code
- P01020101 Dental implants
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026774
Other devices from Biotec S.R.L.
Properties
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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