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Ceramic Bracket
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.83.2121
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 ROTH 0,022 U1L (21) FDA UDI
- Model / Reference
- 10.83.2121 EUDAMEDFDA UDI
- Description
- CERAMIC BRACKET ICERAM ROTH 0,022 U1L (21) FDA UDI
Identifiers
- Catalog Number
- 10.83.2121 FDA UDI
- Primary DI / UDI-DI
- 07908470708262 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
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
Ceramic Bracket by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 acbb019a-10d6-42d0-a592-5514085ab3ed 61 fields · synced Jun 9, 2026
- FDA UDI d925e0c6-5674-4f67-b30e-49f868f0807e 35 fields · synced May 30, 2026