FDA.reportPublic FDA data

ApexCal

Primary DI
07615208008661
Brand
ApexCal
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
595915AN
Catalog number
595915AN
Device description
ApexCal Refill 2x2.5 g
Published
2022-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
DVIV595915AN1PreviousHIBCC0
07615208008661PrimaryGS10
07615208433258Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208008661076152080086617615208008661
07615208433258076152084332587615208433258

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic temporary cementA viscous material intended for the temporary obturation of a prepared root canal, to maintain relative sterility between procedures and facilitate healing. Commonly referred to as temporary filling or sealer, it is typically a zinc or calcium cement-based paste that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a prefilled tube or syringe; some types require the use of a separate sealer. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
448015938
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208474398Clinical Auxiliary (no MD)7608167608162026-07-14
07615208592634Ivotion Dent7711817711812026-07-09
07615208592689Ivotion Dent7711827711822026-07-09
07615208592696Ivotion Dent7711857711852026-07-09
07615208592702Ivotion Dent7711867711862026-07-09
07615208592719Ivotion Dent7711877711872026-07-09
07615208585728Ivotion Base7712057712052026-07-08
07615208585735Ivotion7712077712072026-07-08
07615208585742Ivotion7712087712082026-07-08
07615208585759Ivotion7712097712092026-07-08
07615208585766Ivotion7712107712102026-07-08
07615208585773Ivotion7712117712112026-07-08
07615208585780Ivotion7712127712122026-07-08
07615208585797Ivotion7712137712132026-07-08
07615208585803Ivotion7712147712142026-07-08
07615208585810Ivotion7712157712152026-07-08
07615208585827Ivotion7712167712162026-07-08
07615208585834Ivotion7712177712172026-07-08
07615208585841Ivotion7712187712182026-07-08
07615208543582IPS e.max Zirconia7644027644022026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850440008582ActaCal Calcium Hydroxide PasteEngineered Endodontics, LLCEJK2026-01-02
00197998302732Solventum™ Vitrebond™Solventum US LLCEJK2025-09-29
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