PQ4 641

GUDID 00883205103673

PQ1 Refill

ULTRADENT PRODUCTS, INC.

Dentine bonding agent/set
Primary Device ID00883205103673
NIH Device Record Key020da806-5f7b-457e-a180-aa62f715beb1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePQ4
Version Model Number641
Catalog Number641
Company DUNS013369913
Company NameULTRADENT PRODUCTS, 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(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com
Phone+1(801)572-4200
Emailcustomerservice@ultradent.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100883205103673 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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