Identity
- Trade Name
- Traxodent Applicator Tip EUDAMEDTraxodent Tips FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Traxodent Tips EUDAMEDTraxodent Applicator Tip FDA UDI
- Model / Reference
- 9007092 EUDAMEDFDA UDI
- Description
- Traxodent Applicator Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783002003 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783TraxodentTipsP9 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
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 material injection cannula, single-use
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
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 02378776-c71b-4a69-a931-cc7f9fe364c1 33 fields · synced Jul 9, 2026
- EUDAMED 9fd6d574-c035-49b7-9965-9e6192f9e969 61 fields · synced Jul 9, 2026