Itena Traxodent Tips TRAEMB20
by Premier Dental Products Company
Ref 7007094 (TRAEMB-20)
Itena Traxodent Tips TRAEMB20 is a Class I device made by Premier Dental Products Company, registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 00348783Trax-ItenaTipXJ) and listed in FDA GUDID since 29 Jun 2022 (UDI-DI 00348783002027), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number00348783Trax-ItenaTipXJ 00348783002027 | Date4 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00348783002027 | Date29 Jun 2022 | StatusListed |
Official records
- EUDAMED public site 00348783Trax-ItenaTipXJ
- AccessGUDID record 00348783002027
Across registries
- EUDAMED Basic UDI-DI 00348783Trax-ItenaTipXJ registered 4 Jun 2026 Active
- FDA GUDID UDI-DI 00348783002027 listed 29 Jun 2022 Listed
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Timeline
- Listed FDA GUDID 00348783002027
- Registered EUDAMED 00348783Trax-ItenaTipXJ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Itena Traxodent Applicator Tip Qty 20 EUDAMEDItena Traxodent Tips GUDID
- Generic name
- Dental material injection cannula, single-use
- Model / reference
- 7007094 (TRAEMB-20) EUDAMEDTRAEMB20 GUDID
- Primary DI / UDI-DI
- 00348783002027
- Basic UDI-DI
- 00348783Trax-ItenaTipXJ
- FDA product code
- KXR
- EMDN code
- Q019006 Dental material application tips and brushes, single-use
- GMDN term
- Dental material injection cannula, single-use
- Device class
- Class I
- Regulation number
- 872.3140
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 7007094 (TRAEMB-20) | TRAEMB20 |
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