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Kit of Brackets 01 case Prescription Roth - Biofuncional Classe III .022" - Hoo…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.10.920Model BRACKETS AND TUBES
Identity
- Trade Name
- Kit of Brackets 01 case Prescription Roth - Biofuncional Classe III .022" - Hook Can./Bicusp. EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Kit of Brackets 01 case Prescription Roth - Biofuncional Classe III .022" - Hook Can./Bicusp. FDA UDI
- Model / Reference
- BRACKETS AND TUBES EUDAMED10.10.920 EUDAMEDFDA UDI
- Description
- Kit of Brackets 01 case Prescription Roth - Biofuncional Classe III .022" - Hook Can./Bicusp. FDA UDI
Identifiers
- Catalog Number
- 10.10.920 FDA UDI
- Primary DI / UDI-DI
- 07895742152116 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742152116 EUDAMED7895742122FU 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
- Portugal 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
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Category: Orthodontic tube
Kit of Brackets 01 case Prescription Roth - Biofuncional Classe III .022" - Hoo… by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED…
Similar devices
Also classified as Orthodontic tube.
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- Ceramic brackets 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07895742152116 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742152116 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (3)
- EUDAMED b04230ea-a846-4f95-9a58-443f4420354d 61 fields · synced Jul 9, 2026
- EUDAMED 0f5fc72f-c954-4f81-9d25-b67250c33ffa 61 fields · synced May 17, 2026
- FDA UDI 4f39fcee-a23c-4532-b33e-6c6b7f412c5e 35 fields · synced May 30, 2026