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Composi-Tight® 3D Fusion™ Matrix System Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref FXHBS02Ref FX-DSO-1Ref FXHB05Ref UN30Ref UN31Ref FXHBS03
Identity
- Trade Name
- Composi-Tight® 3D Fusion™ Matrix System Kit EUDAMEDComposi-Tight® FDA UDIComposi-Tight 3D Fusion FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDIDental matrix band kit FDA UDI
- Device Name
- Bands Family EUDAMED3D Fusion™ Firm Matrix Band Sample Kit: 15 Count (3 of Each Size) FDA UDI3D Fusion™ Firm Matrix Band Mini Kit: 150 Count (30 of Each Size) FDA UDI3D Fusion™ Sectional Matrix System: (6) Full Curve Matrices, (6) Wedges, (1) FX400 Short Ring FDA UDIComposi-Tight 3D Fusion Firm Matrix Bands Sample Kit FDA UDI3D Fusion™ Sectional Matrix System: (25) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring FDA UDI
- Model / Reference
- FXHBS02 EUDAMEDFDA UDIFXHB05 EUDAMEDFDA UDIUN31 EUDAMEDFDA UDIFXHBS03 EUDAMEDFDA UDIUN30 EUDAMEDFDA UDIFX-DSO-1 EUDAMED
- Description
- 3D Fusion™ Firm Matrix Band Sample Kit: 15 Count (3 of Each Size) FDA UDI3D Fusion™ Firm Matrix Band Mini Kit: 150 Count (30 of Each Size) FDA UDI3D Fusion™ Sectional Matrix System: (6) Full Curve Matrices, (6) Wedges, (1) FX400 Short Ring FDA UDIComposi-Tight 3D Fusion Firm Matrix Bands Sample Kit FDA UDI3D Fusion™ Sectional Matrix System: (25) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring FDA UDI
Identifiers
- Catalog Number
- FXHBS02 FDA UDIFXHB05 FDA UDIUN31 FDA UDIFXHBS03 FDA UDIUN30 FDA UDI
- Primary DI / UDI-DI
- 00810038095394 EUDAMEDFDA UDI00810038095363 EUDAMEDFDA UDI00810038096346 EUDAMEDFDA UDI00810038096490 EUDAMEDFDA UDI00810038096339 EUDAMEDFDA UDI00810038090986 EUDAMED
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMEDQ01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDIDental matrix band kit 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
Yes
FDA UDIFDA 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 (11)
- EUDAMED 203547eb-20e6-4d9b-9f69-c1a3b85f35fb 61 fields · synced Jul 31, 2026
- FDA UDI d34f36fb-1348-417f-ad39-1b70adb901e1 35 fields · synced May 26, 2026
- FDA UDI 208fdf3f-6bfa-457d-ade9-b52ffa22a610 35 fields · synced May 27, 2026
- FDA UDI fb539978-b1c4-40b4-af2b-312f7d9e0db9 35 fields · synced May 30, 2026
- FDA UDI 6e31ef8d-6c3e-4d56-89ab-58c5b09c0f38 35 fields · synced May 30, 2026
- FDA UDI bf9bde5f-1548-4323-a0fb-db97adfedc76 35 fields · synced May 30, 2026
- EUDAMED 70ecba68-0d75-4bd9-86e7-266648fc8116 61 fields · synced Jul 8, 2026
- EUDAMED 7663a41e-29d3-4607-acfe-f74b51402d13 61 fields · synced Jul 13, 2026
- EUDAMED de191c38-d6cc-410b-94d5-d3bdba7d941b 61 fields · synced Jul 13, 2026
- EUDAMED 50dbd1d1-197a-4ea3-979f-2dea4cb131f4 61 fields · synced Jul 30, 2026
- EUDAMED fbb55bc9-1a50-4394-bc5b-d73193752eab 61 fields · synced Jul 31, 2026