FDA.reportPublic FDA data

Calcium hydroxide dental cement

Definition
A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.
GUDID devices
145
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00818365020713EdgeTaper Platinum™US ENDODONTICS, LLCETF1BCGP2023-06-25
00818365020720EdgeTaper Platinum™US ENDODONTICS, LLCETF2BCGP2023-06-25
00818365020737EdgeTaper Platinum™US ENDODONTICS, LLCETF3BCGP2023-06-25
00818365020744EdgeTaper Platinum™US ENDODONTICS, LLCETF4BCGP2023-06-25
00818365020751EdgeTaper Platinum™US ENDODONTICS, LLCETF5BCGP2023-06-25
00818365026746EdgeBioCeramic™US ENDODONTICS, LLC8183650200722023-06-25
07540208000387Select Calcium Hydroxide Liner LCZendo Direct AGCAL-LINER2017-09-26
D0026231171Dycal® Radiopaque Calcium Hydroxide CompositionDENTSPLY INTERNATIONAL INC.6231172022-08-16
D6620711106262Patterson®PATTERSON DENTAL SUPPLY, INC.711106262024-05-08
D701VB12ACTIVA TM BioACTIVE- BASE/LINERPULPDENT CORPORATIONVB12016-07-12
D701VB22ACTIVA TM BioACTIVE- BASE/LINERPULPDENT CORPORATIONVB22016-07-12
D9673000110ApaCal ARTPREVEST DENPRO LIMITEDTrial Pack2023-01-03
D967300040Cal LCPREVEST DENPRO LIMITEDTrial Pack2022-12-08
D967300050Cal LCPREVEST DENPRO LIMITEDIntro Pack2022-12-08
D967300050A08Cal LCPREVEST DENPRO LIMITEDEconomy Pack2022-12-08
D9673000510Cal LCPREVEST DENPRO LIMITEDEconomy Pack2023-01-03
D9674000110Nanoseal SPREVEST DENPRO LIMITED10g cartridge2023-01-03
D96740001A05Nanoseal SPREVEST DENPRO LIMITED10g cartridge2022-12-12
D967400050CalplusPREVEST DENPRO LIMITEDTrial Pack2022-12-12
D9674000510CalplusPREVEST DENPRO LIMITEDIntro Pack2023-01-03
D96740005A09CalplusPREVEST DENPRO LIMITEDIntro Pack2022-12-12
D967400060CalplusPREVEST DENPRO LIMITEDEconomy Pack2023-01-03
D9674000600CalplusPREVEST DENPRO LIMITEDEconomy Pack2022-12-12
D967400070CalcigelPREVEST DENPRO LIMITEDTrial Pack2023-01-03
D9674000701CalcigelPREVEST DENPRO LIMITEDTrial Pack2022-12-08
D9674000710CalcigelPREVEST DENPRO LIMITEDIntro Pack2023-01-03
D9674000720CalcigelPREVEST DENPRO LIMITEDRegular Pack2023-01-03
D96740007B06CalcigelPREVEST DENPRO LIMITEDRegular Pack2022-12-08
D967400080CalcigelPREVEST DENPRO LIMITEDEconomy Pack2023-01-03
D9674000802CalcigelPREVEST DENPRO LIMITEDEconomy Pack2022-12-08
D967400310EndosealPREVEST DENPRO LIMITED15g powder2022-12-12
D9674003110EndosealPREVEST DENPRO LIMITED20g powder2023-01-03
D96740031A08EndosealPREVEST DENPRO LIMITED20g powder2022-12-12
D967400370Cerafill RCSPREVEST DENPRO LIMITEDTrial Pack2023-01-03
D9674003704Cerafill RCSPREVEST DENPRO LIMITEDTrial Pack2022-12-12
D9674003710Cerafill RCSPREVEST DENPRO LIMITEDRegular Pack in Plastic Pouch2023-01-03
D9674003720Cerafill RCSPREVEST DENPRO LIMITEDRegular Pack in Box2023-01-03
D96740037A0Cerafill RCSPREVEST DENPRO LIMITEDRegular Pack in Plastic Bag2022-12-12
D96740037B0Cerafill RCSPREVEST DENPRO LIMITEDRegular Pack in Box2022-12-12
D967400410CalApex Automix PastePREVEST DENPRO LIMITED20g2022-12-12
D9674004110CalApexPREVEST DENPRO LIMITED20g2023-01-03
D9674004120CalApex Manual Mix PastePREVEST DENPRO LIMITED20g2023-01-03
D96740041A09CalApexPREVEST DENPRO LIMITED20g2022-12-12
D96740041B0CalApex Manual Mix PastePREVEST DENPRO LIMITED20g2022-12-12
D967400430Zical Ultra Automix PastePREVEST DENPRO LIMITED15g2023-01-03
D9674004301Zical Ultra Automix PastePREVEST DENPRO LIMITED15g2022-12-12
D967400440Zical Ultra PREVEST DENPRO LIMITED15g powder2023-01-03
D9674004402Zical Ultra PREVEST DENPRO LIMITED15g powder2022-12-12
D967400460CalUltraPREVEST DENPRO LIMITED24g2023-01-03
D9674004604CalUltraPREVEST DENPRO LIMITED24g2022-12-08
D9674007A08CalcigelPREVEST DENPRO LIMITEDIntro Pack2022-12-08
00850079280120HexaHexa DentalLLC-00012026-01-21
00850440008582ActaCal Calcium Hydroxide PasteEngineered Endodontics, LLCACP2026-01-02
D161250010AxioPro ARTAxiodent Inc.25001 Trial Pack 2024-10-04
D161250020AxioPro ARTAxiodent Inc.25002 Intro Pack 2024-10-04
D161250040AxioCAL LCAxiodent Inc.25004 Trial Pack 2024-10-04
D161250050AxioCAL LCAxiodent Inc.25005 Intro Pack 2024-10-04
D161250060AxioCAL LCAxiodent Inc.25006 Economy Pack 2024-10-04
D161250080AxioCAL Axiodent Inc.25008 Trial Pack 2024-10-04
D161250090AxioCAL Axiodent Inc.25009 Regular Pack 2024-10-04
D161250100AxioCAL Axiodent Inc.25010 Intro Pack 2024-10-04
D161250110AxioCAL Axiodent Inc.25011 Economy Pack 2024-10-04
D161250150AxioCAL SC Axiodent Inc.25015 Automix Pack 2024-10-04
D161250160AxioCAL SC Axiodent Inc.25016 Manual Mix Pack 2024-10-04
D161250170AxioCAL LC Axiodent Inc.25017 Single 0.5g syringe 2024-10-04
D161250180AxioPro ARTAxiodent Inc.25018 Single 0.5g syringe 2024-10-04
08906110440397MAARC DENTAL-Calcium Hydroxide PowderSHIVA PRODUCTS5002/100B2024-10-02
08906110443619MAARC DENTAL-Calcium Hydroxide Powder (with Barium Sulphate) SHIVA PRODUCTS5002/015B2024-10-02
D161190010AxioBio RCS Axiodent Inc.19001 Trial Pack2024-10-02
D161190020AxioBio RCS Axiodent Inc.19002 Regular Pack Box2024-10-02
D161190030AxioBio RCS Axiodent Inc.19003 Regular Pack Pouch2024-10-02
D161190040AxioBio RCS Axiodent Inc.19004 Single 0.5g syringe2024-10-02
D161190070AxioPexAxiodent Inc.19007 20g2024-10-02
D161190080AxioPexAxiodent Inc.19008 Automix Pack2024-10-02
D161190090AxioPexAxiodent Inc.19009 Manual Mix Pack2024-10-02
D161190100AxioCal+Axiodent Inc.19010 Trial Pack2024-10-02
D161190110AxioCal+Axiodent Inc.19011 Intro Pack2024-10-02
D161190130AxioCal+Axiodent Inc.19013 Economy Pack2024-10-02
D161190150AxioSealAxiodent Inc.19015 15g powder2024-10-02
D161190160AxioSealAxiodent Inc.19016 20g powder2024-10-02