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L3r Minitwin Db/Mtwin 18 Roth 7/-11/2 Bhk
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 328-1410Ref 328-0410
Identity
- Trade Name
- L3R MINITWIN DB/MTWIN 18 ROTH 7/-11/2 BHK EUDAMEDL3R MINITWIN DB/MTWIN 18 ROTH 7/-11/2 EUDAMEDMini-Twin FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- L3R MINITWIN DB/MTWIN 18 ROTH 7/-11/2 BHK EUDAMEDL3R MINITWIN DB/MTWIN 18 ROTH 7/-11/2 EUDAMEDL3R MINI TWIN DB/MTWIN 18 ROTH 7/-11/2 BHK FDA UDI
- Model / Reference
- 328-1410 EUDAMEDFDA UDI328-0410 EUDAMED
- Description
- L3R MINI TWIN DB/MTWIN 18 ROTH 7/-11/2 BHK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989035704 EUDAMEDFDA UDI00889989035483 EUDAMED
- Basic UDI-DI
- B-00889989035704 EUDAMEDB-00889989035483 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
Category: Orthodontic tube
L3r Minitwin Db/Mtwin 18 Roth 7/-11/2 Bhk by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989035704 | 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 dd083b0c-cc4e-4471-baa4-5acdfb33c5eb 61 fields · synced Jul 25, 2026
- EUDAMED 5c1df60c-6c3a-496f-ac36-ead6cc5ae2f4 61 fields · synced May 18, 2026
- FDA UDI a52e4893-086d-4603-91bf-7a27e608a7d6 35 fields · synced May 29, 2026