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Facebow Standard - Ø1, 30mm (.051")
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50.11.001Model THREADS AND BOWS - Class I
Identity
- Trade Name
- Facebow Standard - Ø1,30mm (.051") EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic face bow FDA UDI
- Device Name
- Facebow Standard - Ø1,30mm (.051") FDA UDI
- Model / Reference
- THREADS AND BOWS - Class I EUDAMED50.11.001 EUDAMEDFDA UDI
- Description
- Facebow Standard - Ø1,30mm (.051") FDA UDI
Identifiers
- Catalog Number
- 50.11.001 FDA UDI
- Primary DI / UDI-DI
- 07895742000424 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742130FT EUDAMEDB-07895742000424 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 Standard - Ø1, 30mm (.051") 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 967ba8fd-9725-4b6f-b26d-0df79f76d109 61 fields · synced Aug 3, 2026
- EUDAMED 3f8f7f3c-fec0-4138-8cb4-126337b5234e 61 fields · synced May 19, 2026
- FDA UDI b42a3e10-db25-45ac-82d0-26b0df3b01cb 35 fields · synced May 30, 2026