FDA.reportPublic FDA data

3M™ Sof-Lex™

Primary DI
30605861021792
Brand
3M™ Sof-Lex™
Company
3M COMPANY
Model
1958M
Catalog number
1958M
Device description
"3M™ Sof-Lex™ Square Eyelet Discs Refill, 5/8"" Diameter, Medium, 1958M"
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHJDISK, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50605861021796PackageGS110In Commercial Distribution
30605861021792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060586102179650605861021796
3060586102179230605861021792

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, single-useA dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
830016148
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15
007073877753083M™ Bair Hugger™55077550772026-05-15
007073877753153M™ Bair Hugger™55577555772026-05-15
007073878188833M™ Bair Hugger™54501545012026-05-15
007073878188903M™ Bair Hugger™55001550012026-05-15
007073878189063M™ Bair Hugger™55502555022026-05-15
007073878189133M™ Bair Hugger™58502585022026-05-15
007073878189203M™ Bair Hugger™63501635012026-05-15
007073878189373M™ Bair Hugger™57502575022026-05-15
007073878189443M™ Bair Hugger™45035450352026-05-15
007073878189513M™ Bair Hugger™45535455352026-05-15
007073878189683M™ Bair Hugger™55078550782026-05-15
007073878189753M™ Bair Hugger™55578555782026-05-15
106058610760643M™ Filtek™6555A3-S6555A3-S2026-05-08
106058610773823M™ Filtek™4867A14867A12026-05-08
106058610773993M™ Filtek™4867A24867A22026-05-08
106058610774053M™ Filtek™4867A34867A32026-05-08
106058610774123M™ Filtek™4867B14867B12026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208291643OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2026-04-23
306058610117793M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610117933M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217543M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217783M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262163M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262303M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262543M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262783M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262923M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263393M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263533M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263773M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263913M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264383M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264523M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264763M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264903M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265133M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265373M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265513M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265753M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610685683M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610685753M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610685823M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610685993M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610686433M™ Sof-Lex™3M COMPANYEHJ2026-04-17
00348783011890Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-04-01
00348783011906Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-04-01
00348783011944Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-04-01