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PORTUX CAD/CAM Disc. 98.5X 35mm A1. ML
FDA UDIEUDAMEDClass II (US FDA UDI)
by Productora Y Comercializadora Odontologica New Stetic S A
Identity
- Trade Name
- PORTUX CAD/CAM Disc. 98.5X 35mm A1. ML FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- PORTUX CAD/CAM Disc. 98.5X 35mm A1. ML FDA UDI
- Model / Reference
- 0022576 FDA UDI
- Description
- PORTUX CAD/CAM Disc. 98.5X 35mm A1. ML FDA UDI
Identifiers
- Catalog Number
- 0022576 FDA UDI
- Primary DI / UDI-DI
- 07701126711377 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Temporary dental crown/bridge resin
PORTUX CAD/CAM Disc. 98.5X 35mm A1. ML by Productora Y Comercializadora Odontologica New Stetic S A — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 394c28bc-d954-444b-aba9-3f5051b9b39f 34 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 22, 2026