VITA ENAMIC

GUDID J017EN1EM42826450

VITA ENAMIC® UNIVERSAL, 4M2-HT, EM-10, 5 pcs.

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

Dental appliance fabrication material, ceramic

• Primary Device ID: J017EN1EM42826450
• NIH Device Record Key: 47ca9ac3-4c56-4ce9-a0f9-714ce3825884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITA ENAMIC
• Version Model Number: EN1EM4282645
• 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: false
• 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
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com
• Phone: +1(800)8283839
• Email: info@vitanorthamerica.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J017EN1EM42826450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122269

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: 2024-02-23
• Device Publish Date: 2024-02-15

On-Brand Devices [VITA ENAMIC]

• J017EN1EC42828850: VITA ENAMIC multiColor UNIVERSAL, 4M2-HT, EMC-16, 5 pcs.
• J017EN1EC42028850: VITA ENAMIC multiColor UNIVERSAL, 3M2-HT, EMC-16, 5 pcs.
• J017EN1EC41228850: VITA ENAMIC multiColor UNIVERSAL, 2M2-HT, EMC-16, 5 pcs.
• J017EN1EC40728850: VITA ENAMIC multiColor UNIVERSAL, 1M2-HT, EMC-16, 5 pcs.
• J017EN1EC40628850: VITA ENAMIC multiColor UNIVERSAL, 1M1-HT, EMC-16, 5 pcs.
• J017EC4EC42828850: VITA ENAMIC multiColor for CEREC/inLab, 4M2-HT, EMC-16, 5 pcs.
• J017EC4EC42028850: VITA ENAMIC multiColor for CEREC/inLab, 3M2-HT, EMC-16, 5 pcs.
• J017EC4EC41228850: VITA ENAMIC multiColor for CEREC/inLab, 2M2-HT, EMC-16, 5 pcs.
• J017EC4EC40728850: VITA ENAMIC multiColor for CEREC/inLab, 1M2-HT, EMC-16, 5 pcs.
• J017EC4EC40628850: VITA ENAMIC multiColor for CEREC/inLab, 1M1-HT, EMC-16, 5 pcs.
• J017EPMEM4282765P0: VITA ENAMIC® for PlanMill, 4M2-HT, EM-14, 5 pcs.
• J017EPMEM42827650: VITA ENAMIC® for PlanMill, 4M2-HT, EM-14, 5 pcs.
• J017EPMEM3282765P0: VITA ENAMIC® for PlanMill, 4M2-T, EM-14, 5 pcs.
• J017EPMEM32827650: VITA ENAMIC® for PlanMill, 4M2-T, EM-14, 5 pcs.
• J017EN1EM42826450: VITA ENAMIC® UNIVERSAL, 4M2-HT, EM-10, 5 pcs.
• J017EC4EM42127650: VITA ENAMIC® for CEREC/inLab, 3M3-HT, EM-14, 5 pcs.
• J017EC4EM42126450: VITA ENAMIC® for CEREC/inLab, 3M3-HT, EM-10, 5 pcs.