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Bracket Prescription Roth - Ceramic .022" - 35, 45 - Hook
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.11.012Model BRACKETS AND TUBES
Identity
- Trade Name
- Bracket Prescription Roth - Ceramic .022" - 35,45 - Hook EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Bracket Prescription Roth - Ceramic .022" - 35,45 - Hook FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED10.11.012 EUDAMEDFDA UDI
- Description
- Bracket Prescription Roth - Ceramic .022" - 35,45 - Hook FDA UDI
Identifiers
- Catalog Number
- 10.11.012 FDA UDI
- Primary DI / UDI-DI
- 07895742201197 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742122FU EUDAMEDB-07895742201197 EUDAMED
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, ceramic 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 Prescription Roth - Ceramic .022" - 35, 45 - Hook by Dental Morelli Ltda. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7895742122FU | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7895742122FU | 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 bd03b87f-37d4-48cf-9380-6216fe0219a3 61 fields · synced Jul 10, 2026
- EUDAMED 67eefe19-8764-4aef-8031-082949058d8f 61 fields · synced May 19, 2026
- FDA UDI 8a7f7922-05b8-48a6-ba44-dfc02db108a6 35 fields · synced May 30, 2026