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U3l Symetri Clear Mclaughlin, Bennett & Trevisi .018 0/8/0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 418-1311Model 41*-**** / 746-*
Identity
- Trade Name
- U3L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 0/8/0 EUDAMEDSymetri Clear FDA UDIAdvanSync Rod, set FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDIOrthodontic clasp, metal, custom-made FDA UDI
- Device Name
- SYMETRI CLEAR EUDAMEDU3L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 0/8/0 FDA UDIAdvanSync Rod, set FDA UDI
- Model / Reference
- 41*-**** / 746-* EUDAMED418-1311 EUDAMEDFDA UDIMATER200 FDA UDI
- Description
- U3L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 0/8/0 FDA UDIAdvanSync Rod, set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989083187 EUDAMEDFDA UDI00889989084573 FDA UDI
- Basic UDI-DI
- 0889989-Symetri_Clear-XX EUDAMED
- FDA Product Code
- NJM FDA UDIEJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, ceramic FDA UDIOrthodontic clasp, metal, custom-made FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDIClass I FDA UDI
- Regulation Number
- 872.5470 FDA UDI872.5410 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
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Category: Orthodontic tube
U3l Symetri Clear Mclaughlin, Bennett & Trevisi .018 0/8/0 by Ormco Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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-Symetri_Clear-XX | 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 (3)
- EUDAMED ca1ddff1-ba68-4fd6-81b4-b58306d47a86 61 fields · synced Jul 20, 2026
- FDA UDI 0bff5ab9-fb3c-46b8-bb5a-09171ba8744f 35 fields · synced May 30, 2026
- FDA UDI 52151166-898a-4732-8202-841eb10a4959 34 fields · synced May 30, 2026