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Septoject Sterile Disposable Injection Needle
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K851524Ref 333S/0.4 x 25Ref 333S/0.4 x 21Ref 333S/0.4 x 16Ref 333S/0.3 x 10
Identity
- Trade Name
- Septoject EUDAMED
- Device Name
- Septoject EUDAMED
- Model / Reference
- 333S/0.4 x 25 EUDAMED333S/0.4 x 21 EUDAMED333S/0.4 x 16 EUDAMED333S/0.3 x 10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FR-MF-00001699200063PT EUDAMEDD-FR-MF-00001699200061PP EUDAMEDD-FR-MF-00001699200008PK EUDAMEDD-FR-MF-00001699200002P7 EUDAMED
- Basic UDI-DI
- B-FR-MF-00001699200063PT EUDAMEDB-FR-MF-00001699200061PP EUDAMEDB-FR-MF-00001699200008PK EUDAMEDB-FR-MF-00001699200002P7 EUDAMED
- 510(k) Number
- K851524 FDA 510(k)
- FDA Product Code
- DZM FDA 510(k)
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4730 FDA 510(k)
- Regulation Number
- 872.4730 FDA 510(k)
- Market of Registration
- Ireland EUDAMEDCzechia EUDAMEDFrance EUDAMEDGreece EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Septoject Sterile Disposable Injection Needle by Specialites Septodont — Class I — MDD, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K851524 | Class I | Active |
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Manufacturer
- Manufacturer
- Specialites Septodont
Sources (5)
- FDA 510(k) K851524 24 fields · synced Aug 4, 2026
- EUDAMED 46459030-f0cc-48ae-bdcb-8e52090b124f 61 fields · synced Jul 8, 2026
- EUDAMED 9a405bc6-8634-43c3-a263-dadd521e402c 61 fields · synced Jul 8, 2026
- EUDAMED ff5d6794-da3e-4a29-8b32-098b6d191e71 61 fields · synced Jul 29, 2026
- EUDAMED 528ec9f8-f1de-4a6e-ac98-6a0bc746e703 61 fields · synced Aug 4, 2026