Identity
- Trade Name
- Pro-Matrix - Wide (20pcs) EUDAMEDAstek FDA UDI
- Generic Name
- Dental matrix band tensioner FDA UDI
- Device Name
- Pro-Matrix Retainer Matrix EUDAMEDPro-Matrix 6mm Wide Band FDA UDI
- Model / Reference
- 19027 EUDAMEDFDA UDI
- Description
- Pro-Matrix 6mm Wide Band FDA UDI
Identifiers
- Catalog Number
- 19027 FDA UDI
- Primary DI / UDI-DI
- 10840326423872 EUDAMED00840326423875 FDA UDI
- Basic UDI-DI
- 08434711190000105062224P9 EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band tensioner 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 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pro-Matrix - Wide (20pcs) by Young Innovations, Inc. — 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 | 08434711190000105062224P9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED ab7febfa-bbfc-475d-8253-c6c15bf72dee 61 fields · synced Jul 13, 2026
- FDA UDI a3d8a0b3-5fef-41a6-8afc-a229ead67f28 35 fields · synced May 30, 2026