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Composi-Tight® 3D Fusion™ Sectional Matrix Rings
EUDAMEDClass I (EU MDR)
Ref FX400Ref FX600Ref FX500
Identity
- Trade Name
- Composi-Tight® 3D Fusion™ Sectional Matrix Rings EUDAMED
- Device Name
- Rings Family EUDAMED
- Model / Reference
- FX400 EUDAMEDFX600 EUDAMEDFX500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810038094523 EUDAMED10810038094547 EUDAMED10810038094530 EUDAMED
- Basic UDI-DI
- 081003809RingsTFCH EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Composi-Tight® 3D Fusion™ Sectional Matrix Rings by Garrison Dental Solutions LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809RingsTFCH | Class I | Active |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (3)
- EUDAMED 6d3eef40-05cc-45a9-bcd4-cb804479654e 61 fields · synced Jul 30, 2026
- EUDAMED 7cba47a6-aa3b-406a-b572-e586b91fb66c 61 fields · synced May 18, 2026
- EUDAMED 3cffddd4-3089-4381-81fd-3277d03d87d8 61 fields · synced May 18, 2026