FDA.reportPublic FDA data

ActaCal Calcium Hydroxide Paste

Primary DI
00850440008582
Brand
ActaCal Calcium Hydroxide Paste
Company
Engineered Endodontics, LLC
Model
ACP
Device description
Calcium Hydroxide Paste
Published
2026-01-02
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212475000Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited2022-05-13EJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850440008582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850440008582008504400085828504400085820850440008582

GMDN Terms#

Term, Definition table
TermDefinition
Calcium hydroxide dental cementA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079892178
Device count
1
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
00850440008001TUN Ultrasonic TipE12026-01-02
00850440008025TUN Ultrasonic TipE22026-01-02
00850440008049TUN Ultrasonic TipE32026-01-02
00850440008063TUN Ultrasonic TipE42026-01-02
00850440008087TUN Ultrasonic TipE52026-01-02
00850440008100TUN Ultrasonic TipE62026-01-02
00850440008124Finishing File2004212026-01-02
00850440008131Finishing File2004252026-01-02
00850440008148Finishing File2004312026-01-02
00850440008254TUN Ultrasonic TipR12026-01-02
00850440008278TUN Ultrasonic TipR22026-01-02
00850440008292TUN Ultrasonic TipR32026-01-02
00850440008339IrriGatorESIT30222026-01-02
00850440008346IrriGatorESIT30262026-01-02
00850440008353IrriGatorESITPR272026-01-02
00850440008360IrriGatorESITPR302026-01-02
00850440008377IrriGatorESITPL272026-01-02
00850440008384IrriGatorESITPL302026-01-02
00850440008391ES Cap TipsESCAP2026-01-02
00850440008407EDTAESEDTA2026-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
D967400460CalUltraPREVEST DENPRO LIMITEDEJK2023-01-03