VITA VIONIC BOND

GUDID J017AD9VBK0

VITA VIONIC BOND KIT

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

Dental appliance fabrication material, cured

• Primary Device ID: J017AD9VBK0
• NIH Device Record Key: fdafdb0d-04a9-4087-bc32-ce3ed1442f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITA VIONIC BOND
• Version Model Number: AD9VBK
• 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: 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try
• Special Storage Condition, Specify: Between 0 and 0 *store between 5 and 10°C, protect from sunlight, keep try

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J017AD9VBK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191926

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: 2020-03-03
• Device Publish Date: 2020-02-24

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

• J017LAM040S02850 - VITA AMBRIA: 2024-10-18 VITA AMBRIA®, 4M2-HT, S, 5 pcs.
• J01753654500050 - CEREC MTL Zirconia: 2024-09-03 CEREC MTL Zirconia, A4, mono, 4 pcs. (5365450005)
• J01753654500120 - CEREC MTL Zirconia: 2024-09-03 CEREC MTL Zirconia, C3, mono, 4 pcs. (5365450012)
• J01753654500180 - CEREC MTL Zirconia: 2024-09-03 CEREC MTL Zirconia, BL2, mono, 4 pcs. (5365450018)
• J01753654500250 - CEREC MTL Zirconia: 2024-09-03 CEREC MTL Zirconia, A4, medi, 2 pcs. (5365450025)
• J01753654500320 - CEREC MTL Zirconia: 2024-09-03 CEREC MTL Zirconia, C3, medi, 2 pcs. (5365450032)
• J017AD9VBMDC0 - VITA VIONIC® BOND: 2024-08-19 VITA VIONIC® BOND multiDose COMPLETE
• J017AD9VBMDK0 - VITA VIONIC® BOND: 2024-08-19 VITA VIONIC® BOND multiDose KIT