FDA.reportPublic FDA data

Solventum™ Vitrebond™

Primary DI
00197998302732
Brand
Solventum™ Vitrebond™
Company
Solventum US LLC
Model
EX-1087333
Catalog number
EX-1087333
Device description
Solventum™ Vitrebond™ Pulp Protect Liner/Base, EX-1087333
Published
2025-09-29
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998302732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998302732001979983027321979983027320197998302732

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998001246Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001277Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001369Solventum™ Tegaderm™166416642026-08-23
00197998002861Solventum™ Tegaderm™9132NS9132NS2026-08-23
00197998149016Solventum™ Tegaderm™358435842026-08-23
00197998149047Solventum™ Tegaderm™358235822026-08-23
00197998149078Solventum™ Tegaderm™358735872026-08-23
00197998149382Solventum™ Tegaderm™358635862026-08-23
00197998149412Solventum™ Tegaderm™359335932026-08-23
00197998149443Solventum™ Tegaderm™359035902026-08-23
00197998149474Solventum™ Tegaderm™358835882026-08-23
00197998149504Solventum™ Tegaderm™358935892026-08-23
00197998150340Solventum™ Clinpro™7200M7200M2026-08-23
00197998150371Solventum™ Clinpro™7200W7200W2026-08-23
00197998150401Solventum™ Clinpro™7200FF7200FF2026-08-23
00197998150432Solventum™ Clinpro™7210M7210M2026-08-23
00197998150463Solventum™ Clinpro™7210W7210W2026-08-23
00197998150494Solventum™ Clinpro™7210FF7210FF2026-08-23
00197998150517Solventum™ Clinpro™7220SP7220SP2026-08-23
00197998173523Solventum™ Tegaderm™912491242026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850440008582ActaCal Calcium Hydroxide PasteEngineered Endodontics, LLCEJK2026-01-02
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