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Orthodontic Ceramic Brackets
EUDAMEDClass IIa (EU MDR)
Ref Clever C, Self ligating, Roth 0.022" UL4HModel RothRef Noble, Roth 0.022" LL5Ref Noble, MBT 0.022" LR3HModel MBT
Identity
- Trade Name
- Orthodontic Ceramic Brackets EUDAMED
- Device Name
- Orthodontic Ceramic Brackets EUDAMED
- Model / Reference
- Roth EUDAMEDClever C, Self ligating, Roth 0.022" UL4H EUDAMEDNoble, Roth 0.022" LL5 EUDAMEDMBT EUDAMEDNoble, MBT 0.022" LR3H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942665512815 EUDAMED06942665515571 EUDAMED06942665515212 EUDAMED
- Basic UDI-DI
- 697443505CR010CH EUDAMED697443505CR011CK EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
Orthodontic Ceramic Brackets by Creative Dental — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
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- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
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- 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 | 697443505CR010CH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Creative Dental
- EUDAMED SRN
- CN-MF-000025975
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (5)
- EUDAMED 554c0b02-2449-4395-87bc-a803865cd1f9 61 fields · synced Jul 8, 2026
- EUDAMED 1b341afc-bc06-4602-883e-37b7e25d92b1-1 61 fields · synced Jul 8, 2026
- EUDAMED 1b341afc-bc06-4602-883e-37b7e25d92b1-2 61 fields · synced Jul 8, 2026
- EUDAMED f0d5b1fc-4f7f-4146-9259-19f46145d328-1 61 fields · synced Jul 8, 2026
- EUDAMED f0d5b1fc-4f7f-4146-9259-19f46145d328-2 61 fields · synced Jul 8, 2026