GLUMA DESENSITIZER SINGLE DOSE 40X1 PCE 66001854

GUDID J014660018540

Agent, tooth bonding resin

Heraeus Kulzer GmbH

Dentine bonding agent/set
Primary Device IDJ014660018540
NIH Device Record Keyce72d228-a5f2-45c0-b664-84ca5d8fcb06
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLUMA DESENSITIZER SINGLE DOSE 40X1 PCE
Version Model Number66001854
Catalog Number66001854
Company DUNS315666321
Company NameHeraeus Kulzer GmbH
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ014660018540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-16
Device Publish Date2016-09-15

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