Burkhart 10:1 Temp C&B Material A3.5 76g

GUDID 00854212006646

BURKHART DENTAL SUPPLY CO., THE

Silicone dental impression material
Primary Device ID00854212006646
NIH Device Record Keye0fdb46e-50dc-431a-94cc-7771d3323ee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurkhart 10:1 Temp C&B Material A3.5 76g
Version Model Number72720597
Company DUNS027532357
Company NameBURKHART DENTAL SUPPLY CO., THE
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(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com
Phone(800)562-8176
Emailcustomerservice@burkhartdental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854212006646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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