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Stabilok Dentine Pin Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ECONOMY BLUE JBModel STABILOK DENTINE PIN
Identity
- Trade Name
- STABILOK DENTINE PIN KIT EUDAMEDStabilok FDA UDI
- Generic Name
- Dental restoration retention pin FDA UDI
- Device Name
- ECONOMY BLUE KIT EUDAMEDIntended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 100 single use pins + 5 reusable drills FDA UDI
- Model / Reference
- STABILOK DENTINE PIN EUDAMEDECONOMY BLUE JB EUDAMEDEconomy Blue FDA UDI
- Description
- Intended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 100 single use pins + 5 reusable drills FDA UDI
Identifiers
- Catalog Number
- JB FDA UDI
- Primary DI / UDI-DI
- 05060489370020 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060489370020 EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q010105 RECONSTRUCTION ENDODONTIC PINS EUDAMED
- GMDN Term
- Dental restoration retention pin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.60 Millimeter FDA UDI
Stabilok Dentine Pin Kit by Fairfax Medical Products Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060489370020 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fairfax Medical Products Limited
- EUDAMED SRN
- GB-MF-000025334
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (2)
- EUDAMED 22b05866-dffd-4bef-9984-ae237cc92cec 61 fields · synced Jun 18, 2026
- FDA UDI b5f34936-85a0-40ba-9038-93ca490fe339 36 fields · synced May 30, 2026