Identity
- Trade Name
- Pro-Matrix Curve – Narrow EUDAMEDAstek FDA UDI
- Generic Name
- Dental matrix band tensioner FDA UDI
- Device Name
- Pro-Matrix Retainer Matrix EUDAMEDPro-Matrix Curve Narrow FDA UDI
- Model / Reference
- 19001 EUDAMEDFDA UDI
- Description
- Pro-Matrix Curve Narrow FDA UDI
Identifiers
- Catalog Number
- 19001 FDA UDI
- Primary DI / UDI-DI
- 10843471150082 EUDAMED00843471150085 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
- Romania 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 Curve – Narrow 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 4e69f1ea-2775-485f-aa80-c67dde2881c7 61 fields · synced Jul 9, 2026
- FDA UDI 9d71c248-3a37-4496-8856-344ab1656356 35 fields · synced May 30, 2026