KromaFaze Singles

GUDID 00841396116650

Dust Free Color Changing Alginate Dental Impression Material Fast Set

Kerr Corporation

Alginate dental impression material

Primary Device ID	00841396116650
NIH Device Record Key	bf18092a-42cc-455d-948b-e784ba9a4449
Commercial Distribution Status	In Commercial Distribution
Brand Name	KromaFaze Singles
Version Model Number	27444DX
Company DUNS	199354556
Company Name	Kerr Corporation
Device Count	125
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	true
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
Phone	+18005377123
Email	customercare@kavokerrgroup.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
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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.
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	00841396116650 [Primary]
GS1	10841396116657 [Unit of Use]

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	2
Public Version Date	2018-03-29
Device Publish Date	2017-08-31

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