OptiBond All-In-One 33535

GUDID 10841396107242

One Component, Self-Etching Dental Adhesive; Unidose; Sample - Not For Sale

Kerr Corporation

Dentine bonding agent/set
Primary Device ID10841396107242
NIH Device Record Keycf5e8b15-9e38-4fde-b6ea-bb4f90e9cb49
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiBond All-In-One
Version Model Number33535
Catalog Number33535
Company DUNS199354556
Company NameKerr Corporation
Device Count3
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

Device Dimensions

Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 Milliliter
Total Volume0.54 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396107245 [Unit of Use]
GS110841396107242 [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 Number3
Public Version Date2024-02-16
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

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