FDA.reportPublic FDA data

3M™ Sof-Lex™

Primary DI
30605861068582
Brand
3M™ Sof-Lex™
Company
3M COMPANY
Model
1983RA
Catalog number
1983RA
Device description
3M™ Sof-Lex™ Mandrels, Refill, 1983RA, 3ct
Published
2026-04-17
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
EHJDISK, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50605861068586PackageGS110In Commercial Distribution
30605861068582PrimaryGS10
00605861068581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060586106858650605861068586
3060586106858230605861068582
00605861068581006058610685816058610685810605861068581

GMDN Terms#

Term, Definition table
TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
830016148
Device count
3
DM exempt
true
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
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
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