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Bracket Roth Prescription - Ceramic SLI .022" - 11
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.12.001Model BRACKETS AND TUBES
Identity
- Trade Name
- Bracket Roth Prescription - Ceramic SLI .022" - 11 EUDAMEDMorelli FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- Bracket Roth Prescription - Ceramic SLI .022" - 11 FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED10.12.001 EUDAMEDFDA UDI
- Description
- Bracket Roth Prescription - Ceramic SLI .022" - 11 FDA UDI
Identifiers
- Catalog Number
- 10.12.001 FDA UDI
- Primary DI / UDI-DI
- 07895742242213 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742242213 EUDAMED7895742122FU EUDAMED
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Self-ligating orthodontic bracket FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 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
No
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
Bracket Roth Prescription - Ceramic SLI .022" - 11 by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-07895742242213 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742242213 | 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 f12c82de-a493-4cf7-b5e4-8237e958ac1d 61 fields · synced Jul 26, 2026
- EUDAMED fa15071e-8d0c-44cc-8791-82ce619f4342 61 fields · synced May 18, 2026
- FDA UDI 9815de26-b7ff-4bf8-b404-df33f16e6d1c 35 fields · synced May 30, 2026