Metal Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC PREMIUM ELITE BRACKET FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Metal Brackets EUDAMEDMETAL BRACKET PREMIUM ELITE- MBT 0,022- L3L- W/HOOK FDA UDI
- Model / Reference
- 11.21.2333 EUDAMEDFDA UDI
- Description
- METAL BRACKET PREMIUM ELITE- MBT 0,022- L3L- W/HOOK FDA UDI
Identifiers
- Catalog Number
- 11.21.2333 FDA UDI
- Primary DI / UDI-DI
- 07908470700235 EUDAMEDFDA UDI
- Basic UDI-DI
- 789848890METALLIC2L EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthodontic tube
Metal Brackets by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Orthodontic tube.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 789848890METALLIC2L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- BR-MF-000026426
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED 426c5075-97ba-4092-b138-00de00074363 61 fields · synced Sep 30, 2026
- FDA UDI 788e98e9-70ee-4bc9-9fe3-c70685826b30 34 fields · synced May 29, 2026