FDA.reportPublic FDA data

3M™ Sof-Lex™

Primary DI
30605861021754
Brand
3M™ Sof-Lex™
Company
3M COMPANY
Model
1958SF
Catalog number
1958SF
Device description
"3M™ Sof-Lex™ Square Eyelet Discs, 5/8"" Diameter, 1958SF, Superfine, BulkSlit Rollstock"
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
50605861021758PackageGS110In Commercial Distribution
30605861021754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060586102175850605861021758
3060586102175430605861021754

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
088877192573983M™186018602016-08-03
088877192574043M™1860S1860S2016-08-03
506380604335343M™ Aura™1870+1870+2022-06-02
000511312755393M™186018602016-08-03
000511312755463M™1860S1860S2016-08-03
00051131498556VFlex™180518052016-08-03
00051131498563VFlex™1805S1805S2016-08-03
00051131499966Aura™1870+1870+2016-08-03
000680608569683M186018602024-10-25
000680608581223M1860S1860S2024-10-25
006380604309583M™ Aura™1870+1870+2021-08-26
006380604313443M™ Aura™1870+BULK1870+BULK2020-10-22
006380604335463M™ Aura™1870+1870+2022-06-02
007073874194243M™186018602016-08-03
007073874441293M™1860S1860S2016-08-03
300511312759293M™ Vflex™180418042018-02-21
300511312759363M™ Vflex™1804S1804S2018-02-21
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783011920Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011975Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011982Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011999Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
07615208291643OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2026-04-23
306058610117793M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610117933M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217783M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217923M™ 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