Temp-Bond NE

GUDID 10841396112888

Temporary Crown and Bridge Cement Zinc Oxide Unidose

KERR CORPORATION

Ethoxy benzoic acid dental cement
Primary Device ID10841396112888
NIH Device Record Key442363ca-0151-4318-a659-22c6ef70c615
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemp-Bond NE
Version Model Number31973
Company DUNS847905890
Company NameKERR CORPORATION
Device Count50
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

Device Dimensions

Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 Gram
Weight120 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396112881 [Unit of Use]
GS110841396112888 [Primary]

FDA Product Code

EMACEMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-12-15
Device Publish Date2016-08-31

Devices Manufactured by KERR CORPORATION

00195062046957 - Paper Points2024-07-16 Paper Points - F (Fine)
00195062046964 - Paper Points2024-07-16 Paper Points - M (Medium)
00195062046971 - Paper Points2024-07-16 Paper Points - C (Coarse)
00195062046988 - Paper Points2024-07-16 Paper Points - XC (X - Coarse)
00195062046995 - Paper Points2024-07-16 Paper Points - #15
00195062047008 - Paper Points2024-07-16 Paper Points - # 20
00195062047015 - Paper Points2024-07-16 Paper Points - # 25
00195062047022 - Paper Points2024-07-16 Paper Points - # 30

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