VITA ZETA

GUDID J017C5BCO1240

VITA ZETA HLC BOND COLOR, CO12, 4 g

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

Dental prosthesis veneer resin

• Primary Device ID: J017C5BCO1240
• NIH Device Record Key: e0d8da30-1be3-41cc-bcb0-7bb9d9069bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITA ZETA
• Version Model Number: C5BCO124
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J017C5BCO1240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961434

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-02-25
• Device Publish Date: 2017-02-18

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

• J017BLTKA20 - VITA LUMEX: 2025-02-25 VITA LUMEX® AC TRIAL KIT A2
• J017C44001100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 0M1, 10 g
• J017C44004100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 1M1, 10 g
• J017C44005100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 1M2, 10 g
• J017C44006100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 2L1.5, 10 g
• J017C44007100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 2L2.5, 10 g
• J017C44008100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 2M1, 10 g
• J017C44009100 - VITAVM LC: 2025-02-25 VITA VM LC OPAQUE, 2M2, 10 g