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Orthodontic Key for Expansion Screw Activation
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.02.026Model PATIENT INSTRUMENTS
Identity
- Trade Name
- Orthodontic Key for Expansion Screw Activation EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic palate expander screw key FDA UDI
- Device Name
- Orthodontic Key for Expansion Screw Activation FDA UDI
- Model / Reference
- PATIENT INSTRUMENTS EUDAMED75.02.026 EUDAMEDFDA UDI
- Description
- Orthodontic Key for Expansion Screw Activation FDA UDI
Identifiers
- Catalog Number
- 75.02.026 FDA UDI
- Primary DI / UDI-DI
- 07895742140670 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742182GE EUDAMEDB-07895742140670 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthodontic palate expander screw key FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Dry Heat Sterilization FDA UDI
Orthodontic Key for Expansion Screw Activation by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742182GE | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742182GE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 f7f47edd-9a36-412c-94da-60e7da5c1405 61 fields · synced Jul 10, 2026
- EUDAMED 959a4a2b-8e46-4f25-9e4d-c64ba66748ab 61 fields · synced May 19, 2026
- FDA UDI f3345494-1a39-46d8-bd0a-8c6eda2a29cc 35 fields · synced May 30, 2026