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PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN
FDA UDIClass II (US FDA UDI)
by Productora Y Comercializadora Odontologica New Stetic S A
Identity
- Trade Name
- PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN FDA UDI
- Model / Reference
- 0023317 FDA UDI
- Description
- PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN FDA UDI
Identifiers
- Catalog Number
- 0023317 FDA UDI
- Primary DI / UDI-DI
- 07701126712121 FDA UDI
- 510(k) Number
- K192153 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 25mm B3. MN by Productora Y Comercializadora Odontologica New Stetic S A — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Temporary dental crown/bridge resin.
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- tempofit premium BL — DETAX GmbH · Class II
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Cleared under the same submission
K192153 also covers:
- PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 18mm A3.5. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 18mm B3. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 18mm C1. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 18mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 18mm D3. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 20mm B2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 20mm B3. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 20mm C1. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 20mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 20mm D2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
- PORTUX CAD/CAM Disc. 98.5X 20mm D3. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI b9dbf8b0-ed8f-4a76-8629-c40e58d31355 35 fields · synced Jun 1, 2026