OptiBond All-In-One 33381

GUDID 00841396108105

Single-Component, Self-Etch Dental Adhesive; Bottle Kit

Kerr Corporation

Dentine bonding agent/set
Primary Device ID00841396108105
NIH Device Record Key3176ce06-e6fe-4951-af23-40049825e0ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiBond All-In-One
Version Model Number33381
Catalog Number33381
Company DUNS199354556
Company NameKerr Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Device Dimensions

Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter
Total Volume5.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396108105 [Primary]

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

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 Date2016-08-01

On-Brand Devices [OptiBond All-In-One]

00841396108105Single-Component, Self-Etch Dental Adhesive; Bottle Kit
H290335332Single-Component, Self-Etch Dental Adhesive; 100-Pack Unidose Kit
10841396107242One Component, Self-Etching Dental Adhesive; Unidose; Sample - Not For Sale

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