Prime-Crown

GUDID 00817441022269

temporary Crown material

PRIME DENTAL

Dental crown/bridge resin, temporary Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin
Primary Device ID00817441022269
NIH Device Record Key43957acf-d34b-46e5-bf63-86983295f144
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrime-Crown
Version Model NumberA1
Company DUNS027480775
Company NamePRIME DENTAL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS100817441022269 [Primary]

FDA Product Code

ELZCrown, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-14
Device Publish Date2019-11-06

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-Crown2019-11-14temporary Crown material
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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