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Bracket Prescription M.B.T. - PolySafira .022" - 12
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.33.003Model BRACKETS AND TUBES
Identity
- Trade Name
- Bracket Prescription M.B.T. - PolySafira .022" - 12 EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Bracket Prescription M.B.T. - PolySafira .022" - 12 FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED10.33.003 EUDAMEDFDA UDI
- Description
- Bracket Prescription M.B.T. - PolySafira .022" - 12 FDA UDI
Identifiers
- Catalog Number
- 10.33.003 FDA UDI
- Primary DI / UDI-DI
- 07895742261887 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742261887 EUDAMED7895742122FU 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 M.B.T. - PolySafira .022" - 12 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-07895742261887 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742261887 | 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 2ac697b4-ec5f-42a0-a068-7469c85fec4b 61 fields · synced Oct 6, 2026
- EUDAMED cbc9dd4c-31de-4f0d-ba73-b380d7c84857 61 fields · synced May 17, 2026
- FDA UDI 8290ffd0-204f-4d71-b81d-9b84acef0236 35 fields · synced May 30, 2026