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L3r Symetri Clear Mclaughlin, Bennett & Trevisi .018 0/3/2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 418-1410Model 41*-**** / 746-*
Identity
- Trade Name
- L3R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 0/3/2 EUDAMED1mm 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 EUDAMED1mm AdvanSync Spacer, Pk/2 FDA UDIL3R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 0/3/2 FDA UDI
- Model / Reference
- 41*-**** / 746-* EUDAMED418-1410 EUDAMEDFDA UDIMATER209 FDA UDI
- Description
- 1mm AdvanSync Spacer, Pk/2 FDA UDIL3R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI .018 0/3/2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989083279 EUDAMEDFDA UDI00889989084580 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
L3r Symetri Clear Mclaughlin, Bennett & Trevisi .018 0/3/2 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 6d2cc5de-42c0-48b4-b5ac-d8c4827b5933 61 fields · synced Jun 20, 2026
- FDA UDI ea20c267-918b-4031-9eed-35da587097aa 34 fields · synced May 25, 2026
- FDA UDI aaa9636e-5dbc-41fc-9079-a553fb0a6b4b 35 fields · synced May 27, 2026