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Orthodontic Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref F7073-902
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Orthodontic Brackets EUDAMEDDB BRACKETS 13 MINI DIAG 18 T+7 A+5 BH FDA UDI
- Model / Reference
- F7073-902 EUDAMEDFDA UDI
- Description
- DB BRACKETS 13 MINI DIAG 18 T+7 A+5 BH FDA UDI
Identifiers
- Catalog Number
- F7073-902 FDA UDI
- Primary DI / UDI-DI
- 08033707053781 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707053781 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Orthodontic Brackets by Leone S.p.a. — 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-08033707053781 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED d92307b9-88e8-49ff-93a8-5ea26bd1bd53 61 fields · synced Jul 23, 2026
- FDA UDI 1bd4f9c5-5556-4108-b278-9aed476b5d87 34 fields · synced May 30, 2026