FDA.reportPublic FDA data

Ceramir® Protect LC Syringe

Primary DI
07350052430397
Brand
Ceramir® Protect LC Syringe
Company
Doxa Dental AB
Model
40044
Catalog number
40044
Published
2021-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K202413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202413000LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH2020-11-20EJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350052430397PrimaryGS10
07350052430380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350052430397073500524303977350052430397
07350052430380073500524303807350052430380

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
1.855.369-2872info@CeramirUS.com

Regulatory Flags#

DUNS number
350486340
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350052430182Ceramir Applicator 240027400272023-06-08
07350052430328Ceramir® Restore QuikCap40038400382020-12-31
07350052430335Ceramir® Restore QuikCap40039400392020-12-31
07350052430403Ceramir® Protect LC Syringe40045400452021-07-11
07350052430151Ceramir Crown & Bridge QuikCap400302016-08-15
07350052430168Ceramir Crown & Bridge QuikCap400282016-08-15
07350052430175Ceramir Crown & Bridge QuikCap400292016-08-15
07350052430199Ceramir Crown & Bridge QuikCap400312016-08-15
07350052430236Ceramir Crown & Bridge QuikMix400322017-01-01
07350052430243Ceramir Crown & Bridge QuikMix400332017-01-01
07350052430250Ceramir Crown & Bridge QuikMix400342017-01-01
07350052430281Ceramir Crown & Bridge QuikCap400352017-09-15
07350052430298Ceramir Bioceramic Implant Cement QuikCap40037400372019-03-20
07350052430380Ceramir® Protect LC Syringe40044400442021-07-11
07350052430311Ceramir® Restore QuikCap40039400392020-12-31

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