Matrix Strips
by Crosstex International Inc 2 variants
Ref KSTRIP1000Model Matrix Strips
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0732224MatrixbandJ7 10732224003518 | Date30 Apr 2025 | StatusWithdrawn |
| United States | GUDID listing GUDID | Number10732224003518 | Date19 Aug 2022 | StatusListed |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Dental matrix band, single-use
- Model / Reference
- Matrix Strips, KSTRIP1000
- Primary DI / UDI-DI
- 10732224003518
- Basic UDI-DI
- 0732224MatrixbandJ7
- Unit of Use DI
- 00732224003511
- FDA Product Code
- EKF
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- GMDN Term
- Dental matrix band, single-use
- Device Class
- Class I
- Regulation Number
- 872.4565
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000009642
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Crosstex International, Inc.
Properties
Other properties (21)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No