FluoroCal B-3001

GUDID D757B30010

FluoroCal Unit Dose (.4ml)

BISCO INC.

Dental coating, tooth-desensitizing, professional
Primary Device IDD757B30010
NIH Device Record Key9aa7f361-6b87-41ec-ad1a-4e2639292120
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluoroCal
Version Model NumberB-3001
Catalog NumberB-3001
Company DUNS053529939
Company NameBISCO 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 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+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757B30010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-09-09
Device Publish Date2017-06-12

On-Brand Devices [FluoroCal]

D757B30010FluoroCal Unit Dose (.4ml)
D757B30501K1FluoroCal 50ct Unit Dose Pkg
00810111542548FluoroCal 50ct Unit Dose Pkg Spearmint
00810111542890FluoroCal 50ct Unit Dose Pkg Green Apple
00810111542876FluoroCal 50ct Unit Dose Pkg Bubble Gum
00810111542913FluoroCal - 48ct Unit Dose Pkg Assorted: 16 UDs of each flavor (Bubble Gum, Green Apple, & Spea
00810111542906FluoroCal - 3 Unit Dose Sample Pkg Assorted: 1 UDs of each flavor (Bubble Gum, Green Apple, & S

Trademark Results [FluoroCal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLUOROCAL
FLUOROCAL
88721166 not registered Live/Pending
Bisco Inc.
2019-12-10
FLUOROCAL
FLUOROCAL
87094228 not registered Live/Pending
Bisco, Inc.
2016-07-06
FLUOROCAL
FLUOROCAL
75755818 2545718 Live/Registered
Acton Technologies, Inc.
1999-07-20

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