Ormco EtchFree Bonding Primer, Single Arch Unit Dose Refill
by Ormco Corporation 2 variants
Ref 740-0531
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 | Number0889989-Adh_EtchFree-XC 00889989089585 | Date12 Feb 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- Withdrawn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
- Ormco EtchFree Bonding Primer, Single Arch Unit Dose Refill
- Model / Reference
- 740-0531
- Primary DI / UDI-DI
- 00889989089585
- Basic UDI-DI
- 0889989-Adh_EtchFree-XC
- Direct Marketing DI
- 00889989089585
- EMDN Code
- Q01010104 Dental bonding agents
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- US-MF-000038085
- Authorised representative
- KERR ITALIA SRL IT-AR-000007600
Other devices from Ormco Corporation
Properties
Other properties (13)
- Sterile: No
- Implantable: 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