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Morelli
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 40.02.365Model BANDAS ORTODÔNTICAS
Identity
- Trade Name
- Universal Band for Molars U/LR 36,5mm EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- Universal Band for Molars U/LR 36,5mm FDA UDI
- Model / Reference
- 40.02.365 EUDAMEDFDA UDIBANDAS ORTODÔNTICAS EUDAMED
- Description
- Universal Band for Molars U/LR 36,5mm FDA UDI
Identifiers
- Catalog Number
- 40.02.365 FDA UDI
- Primary DI / UDI-DI
- 07895742004651 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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- Tempra — Ortho Organizers, Inc. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- CONLIN MOLAR BANDS — ORTHO ARCH COMPANY INC · Class I
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 a2659754-356d-4889-b00c-e376dfa4a282 35 fields · synced Jul 8, 2026
- EUDAMED d32b4a2a-9dd6-4c5a-9744-f995b959f554 61 fields · synced Jul 8, 2026