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U3l Damon Q2 022 +7/+5/0 Std Tq - Hook
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 491-9881
Identity
- Trade Name
- Damon Q2 FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- U3L DAMON Q2 022 +7/+5/0 STD TQ - HOOK EUDAMEDU3L DAMON Q2 022 7/5/0 STD TQ - HOOK FDA UDI
- Model / Reference
- 491-9881 EUDAMEDFDA UDI
- Description
- U3L DAMON Q2 022 7/5/0 STD TQ - HOOK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989081800 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989081800 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
U3l Damon Q2 022 +7/+5/0 Std Tq - Hook 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-00889989081800 | 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 ee217e59-ba6d-417f-ae5d-4496c4193c04 61 fields · synced Jul 14, 2026
- FDA UDI 19fcc993-dbe3-47f4-aabf-b8db61d65a70 35 fields · synced May 30, 2026