PORTUX CAD/CAM Disc. 98.5X30mm C1. MN 0024938

GUDID 07701126712060

PORTUX CAD/CAM Disc. 98.5X30mm C1. MN

PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin

• Primary Device ID: 07701126712060
• NIH Device Record Key: 5d284453-b1b5-45df-9a2c-16e0379c3746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTUX CAD/CAM Disc. 98.5X30mm C1. MN
• Version Model Number: 0024938
• Catalog Number: 0024938
• Company DUNS: 880141023
• Company Name: PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07701126712060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192153

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

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