PORTUX CAD/CAM Disc. 98.5X30mm. Meharry Dental Base 0026110

GUDID 07701126713494

PORTUX CAD/CAM Disc. 98.5X30mm. Meharry Dental Base

PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Dental appliance fabrication material, resin

• Primary Device ID: 07701126713494
• NIH Device Record Key: e512da40-8467-42f9-ba78-d27645392f7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTUX CAD/CAM Disc. 98.5X30mm. Meharry Dental Base
• Version Model Number: 0026110
• Catalog Number: 0026110
• 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	07701126713494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192153

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2024-05-16
• Device Publish Date: 2024-05-08

Devices Manufactured by PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

• 07701126900948 - Portux 3D Printing Resing Try-In BL4: 2025-08-19 Portux 3D Printing Resin Try-In BL4 x 500g
• 07701126900955 - PORTUX 3D Printing Resin Try-In BL4: 2025-08-19 PORTUX 3D Printing Resin Try-In BL4 x 1000g
• 07701126900962 - Portux 3D Printing Resin Try-In: 2025-08-19 Portux 3D Printing Resin Try-In A1 x 500g
• 07701126900979 - Portux 3D Printing Resin Try-In.: 2025-08-19 Portux 3D Printing Resin Try-In A2 x 500g
• 07701126901075 - Portux 3D Printing Resin Basic Gray x 500g: 2025-08-19 Portux 3D Printing Resin Basic Gray
• 07701126901150 - Portux 3D Printing Resin Cast: 2025-08-19 Portux 3D Printing Resin Cast x 500g
• 07701126901167 - Portux 3D Printing Resin Try-In: 2025-08-19 Portux 3D Printing Resin Try-In A2 x 1000g
• 07701126901174 - PORTUX 3D Printing Resin Try-In A1: 2025-08-19 PORTUX 3D Printing Resin Try-In A1 x 1000g