Identity
- Trade Name
- Unit- Dose Syringe Dispenser EUDAMEDTraxodent Tips FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, single-component FDA UDI
- Device Name
- Traxodent Tips EUDAMEDUnit- Dose Syringe Dispenser Qty 3 FDA UDI
- Model / Reference
- 9007089 EUDAMEDFDA UDI
- Description
- Unit- Dose Syringe Dispenser Qty 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783002034 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 cartridge-plunging applicator, single-component 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 cartridge-plunging applicator, single-component
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 90bc871e-673f-4539-8b93-fdcedf739729 33 fields · synced Jul 13, 2026
- EUDAMED ad99d0b8-7830-4903-bb48-65cc8130fe00 61 fields · synced Jul 13, 2026