OptiBond Solo Plus 33677

GUDID 10841396107259

A Single Component Adhesive; Unidose; Sample Pack - Not For Sale

Kerr Corporation

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set
Primary Device ID10841396107259
NIH Device Record Key3fb18a51-376d-4f57-b916-58d78f8bf55c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiBond Solo Plus
Version Model Number33677
Catalog Number33677
Company DUNS199354556
Company NameKerr Corporation
Device Count2
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
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 Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter
Total Volume0.2 Milliliter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396107252 [Unit of Use]
GS110841396107259 [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 Date2021-12-16
Device Publish Date2016-08-01

On-Brand Devices [OptiBond Solo Plus]

00841396108136Single Component Total-Etch Adhesive; Bottle Kit
00841396108129Single-Component, Total-Etch Bonding Agent; 100-Pack Unidose Kit
00841396105319Bottle; Refill
10841396105309Single-Component, Total-Etch Bonding Agent; 100-Pack Unidose Packets
10841396107259A Single Component Adhesive; Unidose; Sample Pack - Not For Sale

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