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Orthodontic Ceramic Bracket
EUDAMEDClass IIa (EU MDR)
Ref HTCT-01 Rev.6-6,7
by HT Co., Ltd.
Identity
- Device Name
- Orthodontic Ceramic Bracket EUDAMED
- Model / Reference
- HTCT-01 Rev.6-6,7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800022201452 EUDAMED
- Basic UDI-DI
- 880002220MisoSeriesDG EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Orthodontic tube
Introducing the Orthodontic Ceramic Bracket, a cutting-edge orthodontic device designed for precision and effectiveness. This Class IIa device is engineered with the latest materials and technology to deliver exceptional results, making it an ideal solution for patients seeking a more confident smile.
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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880002220MisoSeriesDG | Class IIa | Active |
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Manufacturer
- Manufacturer
- HT Co., Ltd.
- EUDAMED SRN
- KR-MF-000011619
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (2)
- EUDAMED 77dc296f-9dbe-435d-a286-1c59ca8fd566 61 fields · synced Jul 29, 2026
- EUDAMED 77dc296f-9dbe-435d-a286-1c59ca8fd566-1 61 fields · synced Jun 10, 2026