Identity
- Trade Name
- Tofflemire Matrix Bands x-thin N°15 EUDAMEDTOFFLEMIRE MATRIX BANDS X-THIN N.15 FDA UDI
- Generic Name
- Dental matrix band, reusable FDA UDI
- Device Name
- Matrix Bands and Retainers EUDAMEDTofflemire matrix bands Type 8 matrix bands are stainless steel anatomically preformed bands used in combination with matrix retainers as part of contouring for restorative treatment. It enables to perform restoration with anatomic proximal contours and contact areas, by creating a temporary interproximal surface (contour). The different matrix bands provided by Produits Dentaires differ in geometry and size. All references exist in 2 different thickness: thin (0.05mm) and xthin (0.035mm). Tofflemire matrix retainers secure the appropriate matrix band in place Box of 12 bands - N°15 Adults FDA UDI
- Model / Reference
- 41517 EUDAMEDFDA UDI
- Description
- Tofflemire matrix bands Type 8 matrix bands are stainless steel anatomically preformed bands used in combination with matrix retainers as part of contouring for restorative treatment. It enables to perform restoration with anatomic proximal contours and contact areas, by creating a temporary interproximal surface (contour). The different matrix bands provided by Produits Dentaires differ in geometry and size. All references exist in 2 different thickness: thin (0.05mm) and xthin (0.035mm). Tofflemire matrix retainers secure the appropriate matrix band in place Box of 12 bands - N°15 Adults FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159161974 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916MATRIX_B&RMD EUDAMED
- FDA Product Code
- DYO FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- France 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
Tofflemire Matrix Bands x-thin N°15 by Produits Dentaires SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 764015916MATRIX_B&RMD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED 0fa43300-7059-4beb-bfeb-3af6be0cbc13 61 fields · synced Aug 2, 2026
- FDA UDI 6b66fcce-db99-45f5-b219-dc6095dd788a 34 fields · synced May 30, 2026