TheraBase H-3501PS

GUDID D757H3501PS1

TheraBase 1g Dual Syringe Pkg

BISCO INC.

Dental composite resin
Primary Device IDD757H3501PS1
NIH Device Record Keyda802e2d-e382-4e73-b2f7-cac2d91a7a61
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraBase
Version Model NumberH-3501PS
Catalog NumberH-3501PS
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
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
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
HIBCCD757H3501PS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-03
Device Publish Date2020-11-06

On-Brand Devices [TheraBase]

D757H3501S0TheraBase 1g Dual Syringe
D757H3501PS1TheraBase 1g Dual Syringe Pkg
D757H35001P1TheraBase 8g Dual Syringe Pkg
D757H35000TheraBase 8g Dual Syringe
00810111541374TheraBase 1g Dual Syringe Pkg
00810111541350TheraBase 8g Dual Syringe Pkg
00810111541367TheraBase 1g Dual Syringe
00810111541343TheraBase 8g Dual Syringe

Trademark Results [TheraBase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THERABASE
THERABASE
88798567 not registered Live/Pending
Bisco Inc.
2020-02-14

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