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Orthodontic Wax Protection
EUDAMEDFDA UDIClass I (EU MDR)
Ref 35.33.001Model PROTECTION WAX
Identity
- Trade Name
- Orthodontic Wax Protection EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- Orthodontic Wax Protection FDA UDI
- Model / Reference
- PROTECTION WAX EUDAMED35.33.001 EUDAMEDFDA UDI
- Description
- Orthodontic Wax Protection FDA UDI
Identifiers
- Catalog Number
- 35.33.001 FDA UDI
- Primary DI / UDI-DI
- 07895742191559 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742187GQ EUDAMEDB-07895742191559 EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 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
Orthodontic Wax Protection by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 7895742187GQ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742187GQ | 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 cbb216f8-a370-413b-9790-b1ec1345bb22 61 fields · synced Jul 23, 2026
- EUDAMED d062fe31-a8b3-4736-bd85-b524f26f5361 61 fields · synced May 17, 2026
- FDA UDI 09a26e10-d5a2-477d-803c-b0fdf74c6c81 35 fields · synced May 30, 2026