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U6r Bkt 22 Andrews Hk Fcc 5/-9/10
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 138-0003
Identity
- Trade Name
- U6R BKT 22 ANDREWS HK FCC 5/-9/10 EUDAMEDLegacy brkt FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- U6R BKT 22 ANDREWS HK FCC 5/-9/10 EUDAMEDFDA UDI
- Model / Reference
- 138-0003 EUDAMEDFDA UDI
- Description
- U6R BKT 22 ANDREWS HK FCC 5/-9/10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989018646 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989018646 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
- Italy 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
U6r Bkt 22 Andrews Hk Fcc 5/-9/10 by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989018646 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED d0e5aeba-68bf-41b4-b98a-d3ac40006a17 61 fields · synced Jul 12, 2026
- FDA UDI ab852c0d-31af-4a3b-b42f-877a10ed8da8 35 fields · synced May 30, 2026