FDA.reportPublic FDA data

Filtek Three Shade Flowable Restorative

Primary DI
10605861087145
Brand
Filtek Three Shade Flowable Restorative
Company
Solventum US LLC
Model
EXD-947167
Catalog number
EXD-947167
Device description
Unlabelled Warm Chameleon Flow Syringe 2G
Published
2024-12-11
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
EBFMaterial, tooth shade, resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10605861087145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060586108714510605861087145

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
119004140
Device count
1
DM exempt
true
Kit
true
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
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
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291971Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291988Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292022Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292039Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
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07615208292053Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
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07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
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07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22