KromaFaze Singles

GUDID 00841396116650

Dust Free Color Changing Alginate Dental Impression Material Fast Set

Kerr Corporation

Alginate dental impression material
Primary Device ID00841396116650
NIH Device Record Keybf18092a-42cc-455d-948b-e784ba9a4449
Commercial Distribution StatusIn Commercial Distribution
Brand NameKromaFaze Singles
Version Model Number27444DX
Company DUNS199354556
Company NameKerr Corporation
Device Count125
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com
Phone+18005377123
Emailcustomercare@kavokerrgroup.com

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396116650 [Primary]
GS110841396116657 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-31

Devices Manufactured by Kerr Corporation

00195062037979 - Rubber Base Adhesive2024-11-04 Impression adhesive for Permlastic.
00841396118630 - Permlastic2024-11-04 Impression material base, regular bodied
00841396118647 - Permlastic2024-11-04 Impression material catalyst, regular bodied
00841396118654 - Permlastic2024-11-04 Impression material base, heavy bodied
00841396118661 - Permlastic2024-11-04 Impression material catalyst, heavy bodied
00841396118678 - Permlastic2024-11-04 Impression material base, light bodied
00841396118685 - Permlastic2024-11-04 Impression material catalyst, light bodied
00841396118708 - Permlastic2024-11-04 Impression material, standard package, heavy bodied (base and catalyst)
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