PIC Plus

GUDID 00348783000153

PIC Plus Standard Pack - Pink

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin
Primary Device ID00348783000153
NIH Device Record Keyb07f2c97-ebc2-4a1e-b9d5-59e5f0db3da1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIC Plus
Version Model Number3001550
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
GS100348783000153 [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 Number2
Public Version Date2022-12-15
Device Publish Date2020-01-07

On-Brand Devices [PIC Plus]

00348783000191PIC Plus Sample - White
00348783000184PIC Plus Value Pack- White
00348783000177PIC Plus Value Pack - Pink
00348783000160PIC Plus Standard Pack - White
00348783000153PIC Plus Standard Pack - Pink

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