Disp. Mixing Well #5901 MXWL-007

GUDID D757MXWL0070

BISCO INC.

Dental material mixing surface, chairside, single-use
Primary Device IDD757MXWL0070
NIH Device Record Keyf0444fdd-42bc-4083-bc6f-90ca868acaa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisp. Mixing Well #5901
Version Model NumberMXWL-007
Catalog NumberMXWL-007
Company DUNS053529939
Company NameBISCO INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Device Size Text, specify0
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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 Identifiers

Device Issuing AgencyDevice ID
HIBCCD757MXWL0070 [Primary]

FDA Product Code

KXRAPPLICATOR, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-04
Device Publish Date2018-11-12

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D757B2501A1 - PRE-BOND Resin 3ml Btl2024-02-16
D757B36050 - Ace All-Bond TE Cartrdg(Pouch)2024-02-16
D757B36050P1 - Ace All-Bond TE 4 Cartrdg Pkg2024-02-16
D757B3605PS1 - ACE-All-Bond TE 1 CartridgePkg2024-02-16
D757B36100K1 - ACE All-Bond TE Starter Kit2024-02-16
D757B412010 - Ace Universal Primer A&B Cartridge-Pouch2024-02-16

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