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Premier X5 Sectional Matrix System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 9061172
Identity
- Trade Name
- Premier X5 Wedge Large Blue-Qty 100 EUDAMEDPremier X5 Sectional Matrix System FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Premier X5 Sectional Matrix System EUDAMEDPremier X5 Wedge Large Blue-Qty 100 FDA UDI
- Model / Reference
- 9061172 EUDAMEDFDA UDI
- Description
- Premier X5 Wedge Large Blue-Qty 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783004656 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783X5Wedge2U EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental wedge, 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental wedge, 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
Similar devices
Also classified as Dental wedge, single-use.
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- G-Wedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
- Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
- SoftWedge™ — GARRISON DENTAL SOLUTIONS, L.L.C. · Class I
- Wykle Wedges 17mm Green Color 500 count — WYKLE RESEARCH, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 5db3ee84-bcee-4b42-b7dc-2fcb7b47fb76 33 fields · synced Aug 3, 2026
- EUDAMED ed1fae41-5c42-4d13-88a5-af8412c7217b 61 fields · synced Aug 3, 2026