PIC

GUDID 00348783000146

PREMIER IMPLANT CEMENT VALUE PACK

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00348783000146
NIH Device Record Key96ff5872-64de-4127-bdf3-edd91c6884ad
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIC
Version Model Number3001455
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
GS100348783000146 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-12-15
Device Publish Date2016-09-21

On-Brand Devices [PIC]

00348783000566PIC Syringe 2.5mL Sample
00348783000146PREMIER IMPLANT CEMENT VALUE PACK
00348783000139PIC Standard Pack

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