Premier Universal Primer Sample

GUDID D6913001569

Primer Sample

PREMIER DENTAL PRODUCTS COMPANY

Dentine bonding agent/set
Primary Device IDD6913001569
NIH Device Record Key9d7d4a11-22b0-4148-812b-373e90f737de
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Universal Primer Sample
Version Model Number3001569
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 Datefalse
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
HIBCCD6913001569 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-04
Device Publish Date2020-02-25

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