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
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
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
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

00195062075575 - Allrap2025-06-23 Slip-N-Grip Clear Disposable Half Chair / Stool Cover, 33x37" (length x width).
00195062147043 - Allrap2025-06-23 Slip-N-Grip Chair Cover 29x80 (length X width).
00195062147050 - Allrap2025-06-23 Slip-N-Grip Chair Cover 45x56 (length X width).
00195062147067 - Pinnacle2025-06-23 Clear Patient Chair Sleeve 27.5x24 (length x width).
00195062147074 - Pinnacle2025-06-23 Clear Patient Chair Sleeve 32x32 (length x width).
00195062147081 - Pinnacle2025-06-23 Clear Patient Chair Sleeve 29x79 (length x width).
00195062147098 - Pinnacle2025-06-23 Clear Patient Chair Sleeve 48x56 (length x width).
00195062037979 - Rubber Base Adhesive2024-11-04 Impression adhesive for Permlastic.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.