Prime-Core DC Automix Core Build Up Material

GUDID 00817441023563

Prime-Core DC Automix Core Build Up Material - BLUE - 50g KIT

PRIME DENTAL

Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00817441023563
NIH Device Record Key4dff810f-2a92-4eaf-9b07-b2dad1cca37a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrime-Core DC Automix Core Build Up Material
Version Model Number003-061
Company DUNS027480775
Company NamePRIME DENTAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817441023563 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2017-01-04

Devices Manufactured by PRIME DENTAL

00817441022658 - Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive2023-11-29 A 5th generation, single component, multi-use adhesive and glue.
00817441023136 - Prime Dent Etchant Liquid2023-11-29 Etchant gel and conditioner.
00817441023549 - Scott's Select RC Cream 2-9gm Syringe2020-05-06 Scott's Select RC Cream 2-9gm Syringe
00817441020012 - Prime Dent Visible Light Cure Nano Hybrid Composite Shade2019-11-14 Restorative Composite
00817441020029 - Prime Dent Visible Light Cure Nano Hybrid Composite 2019-11-14 Restorative Composite
00817441022269 - Prime-Crown2019-11-14 temporary Crown material
00817441020005 - Prime-Dent Visible Light Cure Nano-Hybrid Composite2018-07-06 Visible Light Cure Nano-Hybrid Composite
00817441023556 - Prime-Core Chemical Cure Core Build Up2018-07-06 Prime Core Chemical Cure Core Build Up Kit 15g/15g WHITE

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