DUO LINK Luting Comp 2 Syr Pkg A-1920B

GUDID D757A1920B1

BISCO INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device IDD757A1920B1
NIH Device Record Keye01ff3bd-cdc0-487e-8950-88b2edcb4690
Commercial Distribution Discontinuation2020-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDUO LINK Luting Comp 2 Syr Pkg
Version Model NumberA-1920B
Catalog NumberA-1920B
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 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
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]
HIBCCD757A1920B1 [Primary]

FDA Product Code

KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN
KXRAPPLICATOR, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-09-16
Device Publish Date2017-06-12

Devices Manufactured by BISCO INC.

D757G91300K1 - DT LIGHT POST Basic Pkg2020-09-25
D757G91320K1 - DT LIGHT POST System Kit2020-09-25
D757G91620K1 - Transluma Intro. Post Kit2020-09-25
D757G91820K1 - DT Illusion XRO Intro Kit2020-09-25
D757X80692P1 - DT Post Removal Kit2020-09-25
D757X80746P1 - DT Light Post #0.5 (Pkg.of 10)2020-09-25
D757X80751P1 - DT LIGHT POST #1 (Pkg.of 10)2020-09-25
D757X80752P1 - DT LIGHT POST #2 (Pkg.of 10)2020-09-25

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