Itena Traxodent Tips
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Itena Traxodent Applicator Tip Qty 60 EUDAMEDItena Traxodent Tips FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Itena Traxodent Tips EUDAMEDItena Traxodent Applicator Tip Qty 60 FDA UDI
- Model / Reference
- 7007092 (TRAEMB-60) EUDAMEDTRAEMB60 FDA UDI
- Description
- Itena Traxodent Applicator Tip Qty 60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783002010 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783Trax-ItenaTipXJ EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 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 material injection cannula, single-use
Itena Traxodent Tips by Premier Dental Products Company — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 2e3ad360-e106-4497-8e67-4f586c574e33 33 fields · synced Jul 9, 2026
- EUDAMED 312e914d-62c3-4f1a-9081-2759831cb315 61 fields · synced Jul 9, 2026