VITA CAD/CAM MATERIALS

GUDID J017EN1SASETCCM0

VITA CAD/CAM MATERIALS Sample Set UNIVERSAL

Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft

Dental appliance fabrication material, ceramic

• Primary Device ID: J017EN1SASETCCM0
• NIH Device Record Key: ee482e76-5873-4f44-a448-77641c8b7d78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITA CAD/CAM MATERIALS
• Version Model Number: EN1SASETCCM
• Company DUNS: 315165357
• Company Name: Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J017EN1SASETCCM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102128

FDA Product Code

• EIH: POWDER, PORCELAIN

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: 2025-06-30
• Device Publish Date: 2025-06-20

Devices Manufactured by Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft

• J017B50582300 - VITA AKZENT® Plus: 2025-08-26 VITA AKZENT Plus GLAZE LT POWDER, 30 g
• J017BAPF500 - VITA AKZENT® Plus: 2025-08-26 VITA AKZENT Plus POWDER FLUID, 50 ml
• J017A60M120EO0 - VITA PHYSIODENS®: 2025-07-25 VITA PHYSIODENS Posteriores, 0M1, 20E OK
• J017A60M120EU0 - VITA PHYSIODENS®: 2025-07-25 VITA PHYSIODENS Posteriores, 0M1, 20E UK
• J017A60M121EO0 - VITA PHYSIODENS®: 2025-07-25 VITA PHYSIODENS Posteriores, 0M1, 21E OK
• J017A60M121EU0 - VITA PHYSIODENS®: 2025-07-25 VITA PHYSIODENS Posteriores, 0M1, 21E UK
• J017A60M122EO0 - VITA PHYSIODENS®: 2025-07-25 VITA PHYSIODENS Posteriores, 0M1, 22E OK
• J017A60M122EU0 - VITA PHYSIODENS®: 2025-07-25 VITA PHYSIODENS Posteriores, 0M1, 22E UK