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Facebow Medium Hard - Ø1, 15mm (.045")
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50.10.002Model THREADS AND BOWS - Class I
Identity
- Trade Name
- Facebow Medium Hard - Ø1,15mm (.045") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- Facebow Medium Hard - Ø1,15mm (.045") FDA UDI
- Model / Reference
- THREADS AND BOWS - Class I EUDAMED50.10.002 EUDAMEDFDA UDI
- Description
- Facebow Medium Hard - Ø1,15mm (.045") FDA UDI
Identifiers
- Catalog Number
- 50.10.002 FDA UDI
- Primary DI / UDI-DI
- 07895742000462 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742000462 EUDAMED7895742130FT EUDAMED
- FDA Product Code
- KCR FDA UDI
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
- GMDN Term
- Orthodontic face bow FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3220 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
Facebow Medium Hard - Ø1, 15mm (.045") by Dental Morelli Ltda. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-07895742000462 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07895742000462 | 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 6ad082d3-6563-466f-bd55-18365f06ee58 61 fields · synced Jul 10, 2026
- EUDAMED 9ffd3705-eb88-4f6a-8f3b-6118bed874da 61 fields · synced May 19, 2026
- FDA UDI f1d36350-3824-49cc-949a-c75d4142e8db 35 fields · synced May 30, 2026