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Orthodontic Ceramic Bracket
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HTCT-01 Rev.6-6,7
by HT Co., Ltd.
Identity
- Trade Name
- MISO FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Orthodontic Ceramic Bracket EUDAMEDThe MISO bracket is indicated for orthodontic movement of natural teeth FDA UDI
- Model / Reference
- HTCT-01 Rev.6-6,7 EUDAMEDMBS181-555 FDA UDI
- Description
- The MISO bracket is indicated for orthodontic movement of natural teeth FDA UDI
Identifiers
- Catalog Number
- MBS181-555 W/Hook FDA UDI
- Primary DI / UDI-DI
- 08800022201513 EUDAMEDFDA UDI
- Basic UDI-DI
- 880002220MisoSeriesDG EUDAMED
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Chemical FDA UDI
Category: Orthodontic tube
Orthodontic Ceramic Bracket by HT Co., Ltd. — 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 | 880002220MisoSeriesDG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 fcbf28fa-3974-482a-b816-edf3eb3b3e26 61 fields · synced Jun 8, 2026
- FDA UDI 901ac753-2634-4cac-9b50-85b62f8e3163 34 fields · synced May 30, 2026