FDA.reportPublic FDA data

Calasept®Plus

Primary DI
17310230000146
Brand
Calasept®Plus
Company
Directa AB
Model
CalaseptPlus
Catalog number
1240100
Published
2016-09-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895508000CALASEPT PASTEJs Dental Mfg., Inc.1989-12-08EJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17310230000146PrimaryGS10
17310230000740Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023000014617310230000146
1731023000074017310230000740

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
353954381
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17310235115869Directa Cheek Retractor Red Adult5115862022-12-07
17310235115876Directa Cheek Retractor Red Child5115872022-12-07
17310235115906Directa Cheek Retractor Ivory Adult5115902022-12-07
17310235115913Directa Cheek Retractor Ivory Child 5115912022-12-07
17310236901089ProphyCare HAp6901082025-09-01
17310231029993ProphyCare HAp6901082025-09-01
17310234160679DryDent Sublingual X-Small4160672022-12-06
17310230021967PrepSure1.0 mm2025-05-27
17310230021974PrepSure1.5 mm2025-05-27
17310230021981PrepSure2.0 mm2025-05-27
17310230924039PrepSure92403924032025-05-27
17310230004045TrollByteLynx Blue #115412450012022-12-06
17310230004052TrollByteLynx Blue #215413150022022-12-06
17310230004069TrollByteLynx Yellow #115434050012022-12-05
17310230004076TrollByteLynx Yellow #215434150022022-12-05
17310236901195ProphyCareMix Single Dose6901192022-12-07
17310230001228TrollBagPSP #1131904032022-12-06
17310230004922TrollByteEzSoft #1155005102022-12-06
17310230004946TrollByteEzSoft #2155005202022-12-06
17310230006674TrollByteEzSoft #2 (Wave)155006202022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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