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L5r Minitwin Rec Db/Ul 18 Roth Bhk 0/-22/4
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 428-1710
Identity
- Trade Name
- L5R MINITWIN REC DB/UL 18 ROTH BHK 0/-22/4 EUDAMEDMini-Twin FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- L5R MINITWIN REC DB/UL 18 ROTH BHK 0/-22/4 EUDAMEDL5R MINI TWIN REC DB/UL 18 ROTH BHK 0/-22/4 FDA UDI
- Model / Reference
- 428-1710 EUDAMEDFDA UDI
- Description
- L5R MINI TWIN REC DB/UL 18 ROTH BHK 0/-22/4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989044768 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989044768 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
L5r Minitwin Rec Db/Ul 18 Roth Bhk 0/-22/4 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-00889989044768 | 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 (2)
- EUDAMED e80ab650-ba9e-4f81-8aca-6f3679e3b8b2 61 fields · synced Jul 8, 2026
- FDA UDI 4fb05983-a073-4133-8e6f-493d941516ee 35 fields · synced May 30, 2026