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Mini-Twist Kobayashi Hook .012 Pk/100
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 271-0000
Identity
- Trade Name
- MINI-TWIST KOBAYASHI HOOK .012 PK/100 EUDAMEDOrmco FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- MINI-TWIST KOBAYASHI HOOK .012 PK/100 EUDAMEDMINI-TWIST KOBAYASHI HOOK 12 PK/100 FDA UDI
- Model / Reference
- 271-0000 EUDAMEDFDA UDI
- Description
- MINI-TWIST KOBAYASHI HOOK 12 PK/100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989033861 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989033861 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010406 ORTHODONTIC LIGATURES EUDAMED
- GMDN Term
- Orthodontic archwire 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
Dimensions & Sizes
- Size
- Outer Diameter — .012 Inch FDA UDI
Mini-Twist Kobayashi Hook .012 Pk/100 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-00889989033861 | 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 180c638d-4c25-4f0b-a965-0a5b6cc272a8 61 fields · synced Jul 18, 2026
- FDA UDI 70d9cb36-edbe-4630-b49a-f4ba6968402c 35 fields · synced May 29, 2026