Premier Universal Primer

GUDID 00348783000627

Premier Universal Primer

PREMIER DENTAL PRODUCTS COMPANY

Dental prosthesis priming agent
Primary Device ID00348783000627
NIH Device Record Keyc1b848ff-9113-4ef1-aca3-dc53082585fa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Universal Primer
Version Model Number3001568
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783000627 [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 Number2
Public Version Date2023-10-17
Device Publish Date2020-02-25

On-Brand Devices [Premier Universal Primer]

D6913001568Primer
00348783000634Premier Universal Primer Sample
00348783000627Premier Universal Primer

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