Premier X5 Sectional Matrix System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Premier X5 Matrix Refill 4.5 mm -Qty 80 EUDAMEDPremier X5 Sectional Matrix System FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Premier X5 Sectional Matrix System EUDAMEDPremier X5 Matrix Refill 4.5 mm -Qty 80 FDA UDI
- Model / Reference
- 9061161 EUDAMEDFDA UDI
- Description
- Premier X5 Matrix Refill 4.5 mm -Qty 80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783004601 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783X5MatrixRefill4C EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band, single-use 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental matrix band, single-use
Premier X5 Sectional Matrix System by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental matrix band, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI dd75baf4-38b7-4646-90e7-8a75c0c71fd0 33 fields · synced Oct 6, 2026
- EUDAMED 1775a582-9cb0-4b96-b00e-ed128732d7e8 61 fields · synced Jul 26, 2026