Brush&Bond® S284

GUDID 00810000529117

Brush&Bond® Kit

PARKELL, INC.

Dentine bonding agent/set
Primary Device ID00810000529117
NIH Device Record Key71db2743-a82e-4451-9636-35bb512b7849
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrush&Bond®
Version Model NumberS284
Catalog NumberS284
Company DUNS009900424
Company NamePARKELL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com
Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store Brush&Bond in a refrigerator where freezing may occur. Freezing will cause phase separation, which will destroy the product. Store in a dark, cool, low-humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, cool, low humidity environment.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000529117 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-26
Device Publish Date2018-10-26

On-Brand Devices [Brush&Bond®]

00810000529155Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
00810000529124Brush&Bond® Dentin/Enamel Bonding Liquid 3ml.
00810000529117Brush&Bond® Kit
00810000529094Brush&Bond® Universal Liquid 3ml.
00810000529087Brush&Bond® Universal Bonding System
M595S2880Brush&Bond® Kit with Mini/Endo B&B Activator Brushes
M595S2871Brush&Bond® Mini/Endo Activator Brushes (Pkg. of 100 pcs.)
M595S2861Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.)
M595S2850Brush&Bond® Dentin/Enamel Bonding Liquid 3ml.
M595S2840Brush&Bond® Kit
M595S2420Brush&Bond® Universal Liquid 3ml.
M595S2400Brush&Bond® Universal Bonding System
00810000529674Brush&Bond® MAX Bonding Liner
00810000529667Brush&Bond® MAX Kit
10810000529145Brush&Bond® Mini/Endo Activator Brushes (Pkg. of 100 pcs.)
10810000529138Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.)

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