PORTUX CAD/CAM Disc. 98.5X 20mm B3. MN 0023316

GUDID 07701126712114

PORTUX CAD/CAM Disc. 98.5X 20mm B3. MN

PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Temporary dental crown/bridge resin

• Primary Device ID: 07701126712114
• NIH Device Record Key: a4ac9f25-78fb-4f6d-9d4e-c40f35b3f6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTUX CAD/CAM Disc. 98.5X 20mm B3. MN
• Version Model Number: 0023316
• Catalog Number: 0023316
• 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	07701126712114 [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: 2024-03-15
• Device Publish Date: 2024-03-07

Devices Manufactured by PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

• 00770112663119 - Opti-Cryl Pour Acrylic Original X 22 lb: 2024-05-16 Opti-Cryl Pour Acrylic Original X 22 lb
• 07701126615842 - Opti-Cryl Pour Acrylic Liquid X 8 oz: 2024-05-16 Opti-Cryl Pour Acrylic Liquid X 8 oz
• 07701126615897 - Novacryl Self Curing Acrylic Liquid X 8 oz: 2024-05-16 Novacryl Self Curing Acrylic Liquid X 8 oz
• 07701126626336 - O-Cryl Self Curing Acrylic Shade White X 1 lb: 2024-05-16 O-Cryl Self Curing Acrylic Shade White X 1 lb
• 07701126626343 - O-Cryl Self Curing Acrylic Shade Clear X 1 lb: 2024-05-16 O-Cryl Self Curing Acrylic Shade Clear X 1 lb
• 07701126626350 - O-Cryl Self Curing Acrylic Liquid X 8 oz: 2024-05-16 O-Cryl Self Curing Acrylic Liquid X 8 oz
• 07701126626374 - O-Cryl Self Curing Acrylic Shade Clear X 5 lb: 2024-05-16 O-Cryl Self Curing Acrylic Shade Clear X 5 lb
• 07701126631156 - Opti-Cryl Pour Acrylic Original X 1 lb: 2024-05-16 Opti-Cryl Pour Acrylic Original X 1 lb