Identity
- Trade Name
- Pro-Matrix Sample Pack EUDAMEDAstek FDA UDI
- Generic Name
- Dental matrix band tensioner FDA UDI
- Device Name
- Pro-Matrix Retainer Matrix EUDAMEDPro-Matrix Sample Pack (1 x Wide + 1 x Wide Curve) Astek FDA UDI
- Model / Reference
- 19022 EUDAMEDFDA UDI
- Description
- Pro-Matrix Sample Pack (1 x Wide + 1 x Wide Curve) Astek FDA UDI
Identifiers
- Catalog Number
- 19022 FDA UDI
- Primary DI / UDI-DI
- 10843471151201 EUDAMED00843471151204 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 Sample Pack 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 5ae6082f-4d52-46a9-9417-dc036fdb0176 61 fields · synced Jun 17, 2026
- FDA UDI a868ce37-98ae-4af1-a6d8-5e12c3e43665 35 fields · synced May 30, 2026