Metal Self Ligating Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC ULTRA-P BRACKET FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- Metal Self Ligating Brackets EUDAMEDSELF LIGATING BRACKET ORTHOCLIP SLB ULTRA-P- ROTH 0.022"U 3 L W/ HOOK FDA UDI
- Model / Reference
- 10.46.2223 EUDAMEDFDA UDI
- Description
- SELF LIGATING BRACKET ORTHOCLIP SLB ULTRA-P- ROTH 0.022"U 3 L W/ HOOK FDA UDI
Identifiers
- Catalog Number
- 10.46.2223 FDA UDI
- Primary DI / UDI-DI
- 07898488906425 EUDAMEDFDA UDI
- Basic UDI-DI
- 79084707SELFLIGATINGEZ EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Self-ligating orthodontic bracket 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 Self Ligating Brackets by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED…
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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 | 79084707SELFLIGATINGEZ | 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 f458ff9a-1f64-403b-9590-8ea9ac32d9ae 61 fields · synced Jun 18, 2026
- FDA UDI 284a3b34-c255-4aa9-8672-0b4ab9bb0a3b 34 fields · synced May 29, 2026