Temp-Bond Original

GUDID 00841396118838

Automix Syringes and Mixing Tips

KERR CORPORATION

Zinc oxide eugenol dental cement
Primary Device ID00841396118838
NIH Device Record Key0246cd76-e783-4f01-a9a8-f8e66fab4f41
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemp-Bond Original
Version Model Number33215
Company DUNS847905890
Company NameKERR CORPORATION
Device Count2
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com
Phone18005377123
Emailcustomercare@kavokerrgroup.com

Device Dimensions

Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram
Weight23.6 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396118838 [Unit of Use]
GS110841396118835 [Primary]

FDA Product Code

EMBZinc Oxide Eugenol

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-03
Device Publish Date2020-05-26

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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.