Orthodontic Bands
EUDAMEDFDA UDIClass IIa (EU MDR)
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- Orthodontic Bands EUDAMEDCALIBRA 1ST MOLAR BANDS n.LL 34 FDA UDI
- Model / Reference
- E1705-34 EUDAMEDFDA UDI
- Description
- CALIBRA 1ST MOLAR BANDS n.LL 34 FDA UDI
Identifiers
- Catalog Number
- E1705-34 FDA UDI
- Primary DI / UDI-DI
- 08033707018964 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707018964 EUDAMED
- FDA Product Code
- ECM FDA UDI
- EMDN Code
- Q010402 ORTHODONTIC BANDS EUDAMED
- GMDN Term
- Orthodontic metal band 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Orthodontic bands are a popular orthodontic treatment option that uses elastic or metal wires to guide teeth into proper alignment. These devices are known for their effectiveness in correcting misaligned teeth and promoting healthy oral hygiene.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707018964 | 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 67500503-ecbb-485f-8cfa-65f05c60de37 61 fields · synced Jul 21, 2026
- FDA UDI fcb327e2-bd96-4921-a316-67a7ac53f64f 34 fields · synced May 25, 2026