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Facebow Medium Hard Small - Ø1, 15mm (.045")
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50.10.003Model THREADS AND BOWS - Class I
Identity
- Trade Name
- Facebow Medium Hard Small - Ø1,15mm (.045") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- Facebow Medium Hard Small - Ø1,15mm (.045") FDA UDI
- Model / Reference
- THREADS AND BOWS - Class I EUDAMED50.10.003 EUDAMEDFDA UDI
- Description
- Facebow Medium Hard Small - Ø1,15mm (.045") FDA UDI
Identifiers
- Catalog Number
- 50.10.003 FDA UDI
- Primary DI / UDI-DI
- 07895742000479 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742130FT EUDAMEDB-07895742000479 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 Small - Ø1, 15mm (.045") 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 | 7895742130FT | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742130FT | 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 cbd13374-7d98-4095-a80a-c7936b92f7f1 61 fields · synced Jul 27, 2026
- EUDAMED 82df6d9d-d44a-4ddd-bd81-03b2925c314a 61 fields · synced May 19, 2026
- FDA UDI 79546888-f616-457d-a717-83e418c0c2d6 35 fields · synced May 30, 2026