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Orthodontic Long Key for Expansion Screw Activation
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.038Model PATIENT INSTRUMENTS
Identity
- Trade Name
- Orthodontic Long Key for Expansion Screw Activation EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic palate expander screw key FDA UDI
- Device Name
- Orthodontic Long Key for Expansion Screw Activation FDA UDI
- Model / Reference
- PATIENT INSTRUMENTS EUDAMED75.01.038 EUDAMEDFDA UDI
- Description
- Orthodontic Long Key for Expansion Screw Activation FDA UDI
Identifiers
- Catalog Number
- 75.01.038 FDA UDI
- Primary DI / UDI-DI
- 07895742116125 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742116125 EUDAMED7895742182GE 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 Long Key for Expansion Screw Activation by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-07895742116125 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742116125 | 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 4a776449-b446-4664-8578-14ca3cd893f6 61 fields · synced Jun 18, 2026
- EUDAMED ed5dd071-d6f0-4195-9b2e-32ba8a4e6aef 61 fields · synced May 19, 2026
- FDA UDI c2b9c8ec-5f58-4136-aaba-2d8b0d3f7529 35 fields · synced May 30, 2026