PIC Plus Standard Pack Shade White

GUDID D6913001551

PREMIER IMPLANT CEMENT

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin
Primary Device IDD6913001551
NIH Device Record Key19be6250-1d3d-43e0-aed9-62be74d02cc1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIC Plus Standard Pack Shade White
Version Model Number3001551
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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6913001551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-16
Device Publish Date2020-01-08

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