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Button for Bonding Flat
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30.10.205Model ACCESSORIES - Class IIa
Identity
- Trade Name
- Button for Bonding Flat EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic aligner auxiliary attachment kit FDA UDI
- Device Name
- Button for Bonding Flat FDA UDI
- Model / Reference
- ACCESSORIES - Class IIa EUDAMED30.10.205 EUDAMEDFDA UDI
- Description
- Button for Bonding Flat FDA UDI
Identifiers
- Catalog Number
- 30.10.205 FDA UDI
- Primary DI / UDI-DI
- 07895742006105 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742183GG EUDAMEDB-07895742006105 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 for Bonding Flat by Dental Morelli Ltda. — Class IIa — MDD, MDR, 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/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742183GG | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7895742183GG | 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 c3eccc70-033c-4c5e-aef2-11b9ba58bfd9 61 fields · synced Jul 31, 2026
- EUDAMED ae5af28b-00b2-47c1-91c3-304f5ae3dabc 61 fields · synced May 17, 2026
- FDA UDI e5dab6b9-f5c5-4904-872c-b0d043b33811 35 fields · synced May 30, 2026