Metal Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- ORTHOMETRIC TUBES PREMIUM SERIES FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Metal Brackets EUDAMEDBONDING TUBES PREMIUM SERIES MBT 0,022- SINGLE 2° MOL LOWER RIGHT (47) FDA UDI
- Model / Reference
- 20.12.1047 EUDAMEDFDA UDI
- Description
- BONDING TUBES PREMIUM SERIES MBT 0,022- SINGLE 2° MOL LOWER RIGHT (47) FDA UDI
Identifiers
- Catalog Number
- 20.12.1047 FDA UDI
- Primary DI / UDI-DI
- 07898488908900 EUDAMEDFDA UDI
- Basic UDI-DI
- 789848890METALLIC2L EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic tube 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 - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Orthodontic tube.
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- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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 7dfecb5a-5d58-442a-a372-c03c13e25442 61 fields · synced Jun 8, 2026
- FDA UDI 56796bbf-9328-444d-bca3-4577890669fa 34 fields · synced May 30, 2026