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Tofflemire Matrix Retainers Junior + 12 ass.bands
EUDAMEDFDA UDIClass I (EU MDR)
Ref 41501
Identity
- Trade Name
- Tofflemire Matrix Retainers Junior + 12 ass.bands EUDAMEDTOFFLEMIRE MATRIX RETAINERS JUNIOR + 12 ass. bands FDA UDI
- Generic Name
- Dental matrix band retainer FDA UDI
- Device Name
- Matrix Bands and Retainers EUDAMEDThe Tofflemire matrix retainer exists in 3 different size/configuration (Universal, Junior, Senior). Tofflemire matrix bands and Nystroem Type 8 matrix bands are available respectively in 7 different shapes & 2 different thickness (thin and x-thin) and in 6 different shapes & 2 different thickness (thin and x-thin). Assortments exist including retainers and bands or different bands configurations. Box FDA UDI
- Model / Reference
- 41501 EUDAMEDFDA UDI
- Description
- The Tofflemire matrix retainer exists in 3 different size/configuration (Universal, Junior, Senior). Tofflemire matrix bands and Nystroem Type 8 matrix bands are available respectively in 7 different shapes & 2 different thickness (thin and x-thin) and in 6 different shapes & 2 different thickness (thin and x-thin). Assortments exist including retainers and bands or different bands configurations. Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159162216 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916MATRIX_B&RMD EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band retainer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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 Retainers Junior + 12 ass.bands by Produits Dentaires SA — 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 | 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 098d6dfc-9864-4d53-8e8c-89588add8737 61 fields · synced Oct 9, 2026
- FDA UDI acb0fa7a-4ab7-4a54-b3ab-328edb158d31 34 fields · synced May 30, 2026