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F/Bow Britegear Short #3 044 Yellow
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 200-0423
Identity
- Trade Name
- Brite-Gear FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- F/BOW BRITEGEAR SHORT #3 044 YELLOW EUDAMEDFacebow SHORT #3 044 YELLOW FDA UDI
- Model / Reference
- 200-0423 EUDAMEDFDA UDI
- Description
- Facebow SHORT #3 044 YELLOW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989023527 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989023527 EUDAMED
- FDA Product Code
- DZB FDA UDI
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
- GMDN Term
- Orthodontic face bow FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
F/Bow Britegear Short #3 044 Yellow 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-00889989023527 | 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 5af54363-15ac-488c-8651-9237da1895e5 61 fields · synced Jun 18, 2026
- FDA UDI 23438b04-26e2-4ae6-bf28-8865a51316cc 35 fields · synced May 30, 2026