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Composi-Tight® 3D Fusion™ Matrix System Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref FXB02
Identity
- Trade Name
- Composi-Tight® 3D Fusion™ Matrix System Kit EUDAMEDComposi-Tight® FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Bands Family EUDAMED3D Fusion™ Full Curve Matrix Band Kit: 210 Count (30) Red, (30) Blue, (50) Gray, (50) Purple, (50) Green FDA UDI
- Model / Reference
- FXB02 EUDAMEDFDA UDI
- Description
- 3D Fusion™ Full Curve Matrix Band Kit: 210 Count (30) Red, (30) Blue, (50) Gray, (50) Purple, (50) Green FDA UDI
Identifiers
- Catalog Number
- FXB02 FDA UDI
- Primary DI / UDI-DI
- 00810038095288 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Composi-Tight® 3D Fusion™ Matrix System Kit by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809BandsTFXZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 3b0e475c-b1be-46d4-8166-bbc3a2c928ac 61 fields · synced Jul 10, 2026
- FDA UDI 594a37b3-6f8b-4b2e-9ef7-5a89f4a3c8ac 35 fields · synced May 30, 2026