CompCORE AF

GUDID 00348783000771

CompCore AF SYRINGE MIX STACK- A3

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00348783000771
NIH Device Record Key7ae20f28-6c57-4425-a61a-bff999e4c163
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompCORE AF
Version Model Number3001513
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
GS100348783000771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-10-16
Device Publish Date2016-09-16

On-Brand Devices [CompCORE AF]

00348783000801CompCore AF Syringe Mix Stack - A3 (9 gr) Blister
00348783000795CompCore AF Syringe Mix Stack -White (9 gr) Blister
00348783000788CompCore AF SYRINGE MIX STACK-BLUE
00348783000771CompCore AF SYRINGE MIX STACK- A3
00348783000764CompCore AF SYRINGE MIX STACK-WHITE
00348783000740COMPCORE AF DUAL CURE A3 REFILL
00348783000733COMPCORE AF DUAL CURE WHITE REFILL
00348783000726COMPCORE AF DUAL CURE A3 INTRO KIT
00348783000719COMPCORE AF DUAL CURE WHITE INTRO KIT

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