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Morelli
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 40.22.405Model BANDAS ORTODÔNTICAS
Identity
- Trade Name
- Anatomic Band for Molars U/LR 40,5mm EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- Anatomic Band for Molars U/LR 40,5mm FDA UDI
- Model / Reference
- 40.22.405 EUDAMEDFDA UDIBANDAS ORTODÔNTICAS EUDAMED
- Description
- Anatomic Band for Molars U/LR 40,5mm FDA UDI
Identifiers
- Catalog Number
- 40.22.405 FDA UDI
- Primary DI / UDI-DI
- 07895742207908 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742224G5 EUDAMED
- FDA Product Code
- DYO 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
- Portugal 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthodontic metal band
Morelli by Dental Morelli Ltda — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic metal band.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda
Sources (2)
- FDA UDI b13c0d2e-673d-4594-9b64-265618e40ee5 35 fields · synced Sep 30, 2026
- EUDAMED bccda474-9e86-4abc-b20f-d8f0ad133c0e 61 fields · synced Jul 8, 2026