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 EUDAMEDDB BRACKET 45 EXTREMO NO-Ni 22 T-22 BH FDA UDI
- Model / Reference
- F9210-945 EUDAMEDFDA UDI
- Description
- DB BRACKET 45 EXTREMO NO-Ni 22 T-22 BH FDA UDI
Identifiers
- Catalog Number
- F9210-945 FDA UDI
- Primary DI / UDI-DI
- 08033707059783 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033707059783 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
Our Orthodontic Brackets device is a Class IIa medical device designed to facilitate accurate and efficient orthodontic treatment. Made from high-quality materials, these brackets are engineered to provide optimal stability and support for patients undergoing orthodontic therapy.
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-08033707059783 | 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 f04c22cf-edd0-489f-b0e9-f23c0f854002 61 fields · synced Jul 12, 2026
- FDA UDI 7e2eee51-be11-4865-8df5-a1aa1f7e736e 34 fields · synced May 25, 2026