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Button Welding
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30.10.105Model ACCESSORIES - Class IIa
Identity
- Trade Name
- Button Welding EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic aligner auxiliary attachment kit FDA UDI
- Device Name
- Button Welding FDA UDI
- Model / Reference
- ACCESSORIES - Class IIa EUDAMED30.10.105 EUDAMEDFDA UDI
- Description
- Button Welding FDA UDI
Identifiers
- Catalog Number
- 30.10.105 FDA UDI
- Primary DI / UDI-DI
- 07895742006075 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742006075 EUDAMED7895742183GG EUDAMED
- FDA Product Code
- ECN FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic aligner auxiliary attachment kit 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 tube
Button Welding by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742006075 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742006075 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED fa3969dc-9485-4cfb-b65b-91991cd1b454 61 fields · synced Jul 26, 2026
- EUDAMED b27d734e-3495-493e-bd4f-9d375d2107bc 61 fields · synced May 19, 2026
- FDA UDI 2be3e2b0-7bf6-4298-8775-9c4e53f74471 35 fields · synced May 30, 2026