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Symetri Clear Mclaughlin, Bennett & Trevisi Upper 5-5 With Hooks On 3 .018
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 746-2105Model 41*-**** / 746-*
Identity
- Trade Name
- SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 5-5 WITH HOOKS ON 3 .018 EUDAMEDSymetri Clear FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- SYMETRI CLEAR EUDAMEDSYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 5-5 WITH HOOKS ON 3 .018 FDA UDI
- Model / Reference
- 41*-**** / 746-* EUDAMED746-2105 EUDAMEDFDA UDI
- Description
- SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 5-5 WITH HOOKS ON 3 .018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989083408 EUDAMED00889989084771 FDA UDI
- Basic UDI-DI
- 0889989-Symetri_Clear-XX 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
Yes
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
Yes
FDA UDI
Category: Orthodontic tube
Symetri Clear Mclaughlin, Bennett & Trevisi Upper 5-5 With Hooks On 3 .018 by Ormco Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID…
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Also classified as Orthodontic tube.
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- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172845 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0889989-Symetri_Clear-XX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (3)
- EUDAMED 25ae4101-fc81-4b21-a2ae-572b98a3a6e0 61 fields · synced Sep 17, 2026
- FDA UDI 610109f9-e2e3-4d69-8e91-7946f288a090 35 fields · synced May 30, 2026
- FDA 510(k) K172845 1 fields · synced May 18, 2026