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Intraoral Archwire Superelastic Large NiTi - Rectangular 0, 53x0, 63mm (.021"x.…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50.62.015Model WIRES AND BOWS - Class IIa
Identity
- Trade Name
- Intraoral Archwire Superelastic Large NiTi - Rectangular 0,53x0,63mm (.021"x.025") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Intraoral Archwire Superelastic Large NiTi - Rectangular 0,53x0,63mm (.021"x.025") FDA UDI
- Model / Reference
- WIRES AND BOWS - Class IIa EUDAMED50.62.015 EUDAMEDFDA UDI
- Description
- Intraoral Archwire Superelastic Large NiTi - Rectangular 0,53x0,63mm (.021"x.025") FDA UDI
Identifiers
- Catalog Number
- 50.62.015 FDA UDI
- Primary DI / UDI-DI
- 07895742000233 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742000233 EUDAMED7895742172GB EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic archwire 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
Intraoral Archwire Superelastic Large NiTi - Rectangular 0, 53x0, 63mm (.021"x.… by Dental Morelli Ltda. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED…
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-07895742000233 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07895742000233 | 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 c46bdbd9-fb69-49bd-b383-38fdc00610e4 61 fields · synced Jun 19, 2026
- EUDAMED 08feb859-5c2e-42d4-8849-b04a5be5cddb 61 fields · synced May 17, 2026
- FDA UDI f7fcb7c9-8cb3-4925-9f58-e7d7041b9cd6 35 fields · synced May 30, 2026