← Back to catalogue
Kit 5x5 Biomax 022 Roth Hk 3, 4, 5 W/20
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05.04.0390Model Orthodontic Brackets
Identity
- Trade Name
- KIT 5X5 BIOMAX 022 ROTH HK 3,4,5 W/20 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Kit 5x5 BioMax 022 Roth Hk 3,4,5 w/20 FDA UDI
- Model / Reference
- Orthodontic Brackets EUDAMED05.04.0390 EUDAMEDFDA UDI
- Description
- Kit 5x5 BioMax 022 Roth Hk 3,4,5 w/20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439249530 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439205J4 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic tube
Kit 5x5 Biomax 022 Roth Hk 3, 4, 5 W/20 by Aditek do Brasil SA — Class IIa — MDR, 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7899439205J4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (2)
- EUDAMED 1373b60c-8d50-457f-82e9-6e16e1c5e4a8 61 fields · synced Jun 18, 2026
- FDA UDI 12a55c41-a3e8-4f40-89f3-c8bcc99b9173 33 fields · synced May 30, 2026