Ceramic Bracket
EUDAMEDFDA UDIClass IIa (EU MDR)
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- CERAMIC BRACKET ICERAM FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Ceramic Bracket EUDAMEDCERAMIC BRACKET ICERAM MBT 0,022 L12RL (31/32/41/42) FDA UDI
- Model / Reference
- 10.84.2231 EUDAMEDFDA UDI
- Description
- CERAMIC BRACKET ICERAM MBT 0,022 L12RL (31/32/41/42) FDA UDI
Identifiers
- Catalog Number
- 10.84.2231 FDA UDI
- Primary DI / UDI-DI
- 07908611202697 EUDAMEDFDA UDI
- Basic UDI-DI
- 79084707CERAMICW5 EUDAMED
- 510(k) Number
- K222847 FDA UDI
- 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
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthodontic tube
Ceramic Bracket 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 | 79084707CERAMICW5 | 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 cd298760-9a31-4423-b288-1d5d29a08eca 61 fields · synced Aug 1, 2026
- FDA UDI e10433bb-f857-4d9f-985d-98ade0d6ea15 35 fields · synced May 30, 2026