Identity
- Trade Name
- Master Series Bracket EUDAMEDMaster Series FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Master Series Bracket EUDAMEDDB BKT MASTER UL CUSP 018 T-2 A+10 R4M FDA UDI
- Model / Reference
- 390-0111 EUDAMEDFDA UDI
- Description
- DB BKT MASTER UL CUSP 018 T-2 A+10 R4M FDA UDI
Identifiers
- Catalog Number
- 390-0111 FDA UDI
- Primary DI / UDI-DI
- 00190746098987 EUDAMEDFDA UDI
- Basic UDI-DI
- 01907460000134DQ 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
- Netherlands 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Orthodontic tube
Master Series Bracket by American Orthodontics — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
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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 | 01907460000134DQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- American Orthodontics
- EUDAMED SRN
- US-MF-000007702
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED bf3f511f-b038-4515-af8d-0315aa650f9b 61 fields · synced Jun 18, 2026
- FDA UDI 4e362f54-c12b-472f-8822-964f84aa084f 35 fields · synced May 30, 2026