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Bracket Easyclip+ Passive 018 Roth Lr3 Hk -11°t 5°a 2°o W/5
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05.20.0343Model Orthodontic Brackets
Identity
- Trade Name
- BRACKET EASYCLIP+ PASSIVE 018 ROTH LR3 HK -11°T 5°A 2°O W/5 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Bracket EasyClip+ Passive 018 Roth LR3 Hk -11°T 5°A 2°O w/5 FDA UDI
- Model / Reference
- Orthodontic Brackets EUDAMED05.20.0343 EUDAMEDFDA UDI
- Description
- Bracket EasyClip+ Passive 018 Roth LR3 Hk -11°T 5°A 2°O w/5 FDA UDI
Identifiers
- Catalog Number
- 05.20.0343 FDA UDI
- Primary DI / UDI-DI
- 07899439271715 EUDAMEDFDA UDI
- Basic UDI-DI
- 7899439205J4 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
- 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
No
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
Bracket Easyclip+ Passive 018 Roth Lr3 Hk -11°t 5°a 2°o W/5 by Aditek do Brasil SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 |
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Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (2)
- EUDAMED bb04c507-78fc-4e9c-9d04-e9c8d6d6ae1a 61 fields · synced Jun 17, 2026
- FDA UDI ae010670-33fc-41b9-9388-2a2b51427bd3 34 fields · synced May 30, 2026