KromaFaze

GUDID 10841396116671

Dust Free Color Changing Alginate Dental Impression Material Fast Set

Kerr Corporation

Alginate dental impression material

• Primary Device ID: 10841396116671
• NIH Device Record Key: 6a697d54-15b9-4354-9d34-5fcebdcf54ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KromaFaze
• Version Model Number: 27452DX
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 9
• 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: 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: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396116674 [Unit of Use]
GS1	10841396116671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160441

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-11
• Device Publish Date: 2017-08-31

On-Brand Devices [KromaFaze]

• 10841396116695: Dust Free Color Changing Alginate Dental Impression Material Regular Set
• 10841396116688: Dust Free Color Changing Alginate Dental Impression Material Regular Set Value Pak
• 10841396116671: Dust Free Color Changing Alginate Dental Impression Material Fast Set
• 10841396100946: Dust Free Color Changing Alginate Dental Impression Material Fast Set Value Pack