Fusion™ Anterior Matrix Kit
by Garrison Dental Solutions LLC 3 variants
Ref ANK02
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081003809BandsTFXZ 00810038090078 | Date30 Sep 2025 | StatusActive |
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- Withdrawn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 — CE/MDR Active
Specification
- Device Name
- Bands Family
- Model / Reference
- ANK02
- Primary DI / UDI-DI
- 00810038090078
- Basic UDI-DI
- 081003809BandsTFXZ
- EMDN Code
- Q01010199 Dental restoration devices - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000004112
- Authorised representative
- Eurolink Europe Compliance Limited IE-AR-000002852
From the manufacturer
Manufacturer's product page: Quad Sectional Matrix System Intro Kit (QR-KHF-10)
Other devices from Garrison Dental Solutions LLC
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