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Head Master Passiv-zylindrisch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6504SOModel 16202
Identity
- Trade Name
- Head Master Passiv-zylindrisch EUDAMEDEDENTA FDA UDI
- Generic Name
- Root canal post kit FDA UDI
- Device Name
- Wurzelstifte EUDAMEDHeadMaster Passive-cylindrical FDA UDI
- Model / Reference
- 16202 EUDAMED6504SO EUDAMEDFDA UDI
- Description
- HeadMaster Passive-cylindrical FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3126504SO1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216202DF EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q010105 RECONSTRUCTION ENDODONTIC PINS EUDAMED
- GMDN Term
- Root canal post kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Head Master Passiv-zylindrisch by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31216202DF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED f40c12ee-1653-4013-a462-6f922f5d5022 61 fields · synced Jun 18, 2026
- FDA UDI 87f8516d-c8ea-467a-96f9-e12d3f857959 33 fields · synced May 30, 2026