Orthodontic Brackets
EUDAMEDFDA UDIClass IIa (EU MDR)
by Leone S.p.a.
Identity
- Trade Name
- LEONE SPA FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Orthodontic Brackets EUDAMEDBRACKETS POS 18 2nd BIC L/L FDA UDI
- Model / Reference
- F2089X04 EUDAMEDFDA UDI
- Description
- BRACKETS POS 18 2nd BIC L/L FDA UDI
Identifiers
- Catalog Number
- F2089X04 FDA UDI
- Primary DI / UDI-DI
- 08033707038795 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707038795 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthodontic tube
Orthodontic Brackets are a type of orthodontic device designed to improve the alignment of teeth. They are used in conjunction with other treatments such as braces or clear aligners.
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
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707038795 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (2)
- EUDAMED afcfa806-e304-4606-a5ed-7ec7ac454244 61 fields · synced Jul 24, 2026
- FDA UDI 691c35a5-0203-4fba-8357-28be5cc6dd06 34 fields · synced May 30, 2026