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L5 Univ Symetri Clear Mclaughlin, Bennett & Trevisi .018 -17/0/0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 418-1710Model 41*-**** / 746-*
Identity
- Trade Name
- L5 UNIV SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 -17/0/0 EUDAMED2mm AdvanSync Spacer, Pk/2 FDA UDISymetri Clear FDA UDI
- Generic Name
- Orthodontic clasp, metal, custom-made FDA UDIOrthodontic bracket, ceramic FDA UDI
- Device Name
- SYMETRI CLEAR EUDAMED2mm AdvanSync Spacer, Pk/2 FDA UDIL5 UNIV SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 -17/0/0 FDA UDI
- Model / Reference
- 41*-**** / 746-* EUDAMED418-1710 EUDAMEDFDA UDIMATER210 FDA UDI
- Description
- 2mm AdvanSync Spacer, Pk/2 FDA UDIL5 UNIV SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 -17/0/0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989083293 EUDAMEDFDA UDI00889989084627 FDA UDI
- Basic UDI-DI
- 0889989-Symetri_Clear-XX EUDAMED
- FDA Product Code
- EJF FDA UDINJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic clasp, metal, custom-made FDA UDIOrthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDIClass II FDA UDI
- Regulation Number
- 872.5410 FDA UDI872.5470 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
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Category: Orthodontic tube
L5 Univ Symetri Clear Mclaughlin, Bennett & Trevisi .018 -17/0/0 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 8eb6b0fd-c96e-4a63-849d-ac51557dda7c 61 fields · synced Jul 15, 2026
- FDA UDI 8b691918-6859-46b3-965a-64893a625fa4 34 fields · synced May 25, 2026
- FDA UDI e30f844c-eced-4cb2-8f06-03280688ba75 35 fields · synced May 30, 2026