FDA.reportPublic FDA data

3M™ Sof-Lex™

Primary DI
30605861068599
Brand
3M™ Sof-Lex™
Company
3M COMPANY
Model
1983HP
Catalog number
1983HP
Device description
3M™ Sof-Lex™ Mandrels, Refill, 1983HP, 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
50605861068593PackageGS110In Commercial Distribution
30605861068599PrimaryGS10
00605861068598Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060586106859350605861068593
3060586106859930605861068599
00605861068598006058610685986058610685980605861068598

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
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
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