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

• J01701075660 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A1, Ø 98.4 x h 14 mm (010.7566)
• J01701075670 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A1, Ø 98.4 x h 18 mm (010.7567)
• J01701075680 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A1, Ø 98.4 x h 22 mm (010.7568)
• J01701075690 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A1, Ø 98.4 x h 25 mm (010.7569)
• J01701075710 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A2, Ø 98.4 x h 14 mm (010.7571)
• J01701075720 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A2, Ø 98.4 x h 18 mm (010.7572)
• J01701075730 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A2, Ø 98.4 x h 22 mm (010.7573)
• J01701075740 - n!ce® Zirconia GT: 2026-01-30 n!ce® Zirconia GT, Multi A2, Ø 98.4 x h 25 mm (010.7574)