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Accent B/T 5sgl F/S Ndx -22tx18 Ll
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 515-0122
Identity
- Trade Name
- ACCENT B/T 5SGL F/S NDX -22TX18 LL EUDAMEDAccent Buccal Tube FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- ACCENT B/T 5SGL F/S NDX -22TX18 LL EUDAMEDFDA UDI
- Model / Reference
- 515-0122 EUDAMEDFDA UDI
- Description
- ACCENT B/T 5SGL F/S NDX -22TX18 LL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989053968 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989053968 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010402 ORTHODONTIC BANDS EUDAMED
- GMDN Term
- Orthodontic tube 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
Accent B/T 5sgl F/S Ndx -22tx18 Ll 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-00889989053968 | 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 d01ccf6b-86e7-408e-91e8-5e5c3a3d66bb 61 fields · synced Jul 8, 2026
- FDA UDI 466de18e-01e3-439f-abd5-deaf6c64f722 35 fields · synced May 26, 2026