FDA.reportPublic FDA data

Vivid PolyCem Kit

Primary DI
D724D4407201
Brand
Vivid PolyCem Kit
Company
PEARSON DENTAL SUPPLIES, INC.
Model
D440720
Published
2016-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EJKLiner, Cavity, Calcium Hydroxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D724D4407201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Zinc polycarboxylate dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
082874108
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D724H6503001Vivid TruEtch 40% H65-03002018-05-09
D724H6503021Vivid TruEtch 40% H65-03022018-05-09
D724H6503041Vivid TruEtch 40% UnisyringeH65-03042018-05-09
D724H6503061Vivid TruEtch 40% Jumbo syringeH65-03062018-05-09
D724H6503081Vivid TruEtch 40% Jumbo syringeH65-03082018-05-09
D724H6503101Vivid TruEtch 10% Kit H65-03102018-05-09
D724Z0603121Vivid Etch 40%z0603122016-06-29
D724Z0603141Vivid Etch 40%Z0603142016-06-29
D724Z0603160Vivid Etch 40%Z0603162016-06-29
D724Z0603180Vivid Etch 40% refillZ0603182016-06-29
D724Z0603200VividEtch 40% Jumbo 60gm RefillZ0603202016-07-07
D724Z0603241Vivid Etch 10%z0603242016-06-29
D724D4407260Vivid TempFill LCD4407462016-06-28
D724S2702701Vivid Root MTA S2702702016-06-30
D724J0800061N'Sure Indicator TapeJ0800062016-07-26
D724J0800081N'Sure Indicator TapeJ0800082016-07-26
D724J0800101N'Sure Indicator TapeJ0800102016-07-26
D724D0104501Vivid Surebond VIID0104502016-06-21
D724D0104521Vivid Surebond VII RefillD0104522016-06-21
D724S2702601Vivid Ceramic PrimeS2702602016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D161250010AxioPro ARTAxiodent Inc.EJK2024-10-04
D161250020AxioPro ARTAxiodent Inc.EJK2024-10-04
D161250040AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250050AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250060AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250080AxioCAL Axiodent Inc.EJK2024-10-04
D161250090AxioCAL Axiodent Inc.EJK2024-10-04
D161250100AxioCAL Axiodent Inc.EJK2024-10-04
D161250110AxioCAL Axiodent Inc.EJK2024-10-04
D161250150AxioCAL SC Axiodent Inc.EJK2024-10-04
D161250160AxioCAL SC Axiodent Inc.EJK2024-10-04
D161250170AxioCAL LC Axiodent Inc.EJK2024-10-04
D161250180AxioPro ARTAxiodent Inc.EJK2024-10-04
00810111542937TheraCal PTBISCO INC.EJK2024-04-03
00810111542944TheraCal PTBISCO INC.EJK2024-04-03
00810118103995NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)NUSMILE, LTD.EJK2023-11-30
08800071200017CleaniCalMARUCHIEJK2023-05-16
106058610830553M™3M COMPANYEJK2023-04-28
D95600APEXH0ApexPaste HardD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956APEXBIO0ApexPaste BioD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956APEXC2G0ApexPaste D.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956CALPSLC0CalPaste LCD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D9673000110ApaCal ARTPREVEST DENPRO LIMITEDEJK2023-01-03
D9673000510Cal LCPREVEST DENPRO LIMITEDEJK2023-01-03
D967400070CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000710CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000720CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D967400080CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03