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U2r Damon Clear .022 -5/+9/0 Lo Tq
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 497-6472Model 497-* / 740-*
Identity
- Trade Name
- U2R DAMON CLEAR .022 -5/+9/0 LO TQ EUDAMEDDamon Clear FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- DAMON CLEAR EUDAMEDU2R .022 -5/+9/0 LO TQ FDA UDI
- Model / Reference
- 497-* / 740-* EUDAMED497-6472 EUDAMEDFDA UDI
- Description
- U2R .022 -5/+9/0 LO TQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989000412 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889989-Damon_Clear-V5 EUDAMED
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 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
U2r Damon Clear .022 -5/+9/0 Lo Tq by Ormco Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0889989-Damon_Clear-V5 | 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 2cb8fe8e-16e4-439a-9661-8016107afb5d 61 fields · synced Jun 18, 2026
- FDA UDI 446b3a93-bbdf-44c8-9d9d-89369da8d669 35 fields · synced May 30, 2026