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
00197998382819Solventum™ Veraflo™ Cleanse Choice™ULTVCC05MDULTVCC05MD2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™ULTVCC05LGULTVCC05LG2026-05-28
00197998470417Solventum™ Bair Hugger™90135901352026-05-15
00197998054457Solventum™ Tegaderm™90112901122026-04-10
00197998054495Solventum™ Tegaderm™90114901142026-04-10
00197998054532Solventum™ Tegaderm™90110901102026-04-10
00197998054570Solventum™ Tegaderm™90120901202026-04-10
00197998470431Solventum™ Bair Hugger™90108901082026-04-29
00197998470455Solventum™ Bair Hugger™90107901072026-04-29
087114280529303M™ Scotchcast™82199821992026-04-18
087114280529543M™ Scotchcast™82299822992026-04-18
087114280529923M™ Scotchcast™82200822002026-04-18
087114280530363M™ Scotchcast™82201822012026-04-18
087114280530503M™ Scotchcast™82202822022026-04-18
040467194325613M™ Scotchcast™82002820022026-04-18
040467194325783M™ Scotchcast™82002A82002A2026-04-18
040467194326223M™ Scotchcast™82002V82002V2026-04-18
040467194326463M™ Scotchcast™82002W82002W2026-04-18
040467194326913M™ Scotchcast™82002B82002B2026-04-18
040467194327143M™ Scotchcast™82002G82002G2026-04-18

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