FDA.reportPublic FDA data

3M™ Sof-Lex™

Primary DI
30605861059153
Brand
3M™ Sof-Lex™
Company
3M COMPANY
Model
5090
Catalog number
5090
Device description
3M™ Sof-Lex™ Pre-Polishing Spiral, 5090, 15ct
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
EJQWHEEL, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50605861059157PackageGS110In Commercial Distribution
30605861059153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060586105915750605861059157
3060586105915330605861059153

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing 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. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
830016148
Device count
1
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
07630243641123KENDADent4You AGEJQ2025-09-17
07630243641130KENDADent4You AGEJQ2025-09-17
07630243641147KENDADent4You AGEJQ2025-09-17
07630243641154KENDADent4You AGEJQ2025-09-17
07630243641161KENDADent4You AGEJQ2025-09-17
07630243641178KENDADent4You AGEJQ2025-09-17
07630243641185KENDADent4You AGEJQ2025-09-17
07630243641192KENDADent4You AGEJQ2025-09-17
07630243641208KENDADent4You AGEJQ2025-09-17
07630243641215KENDADent4You AGEJQ2025-09-17
07630243641222KENDADent4You AGEJQ2025-09-17
07630243641239KENDADent4You AGEJQ2025-09-17
07630243641246KENDADent4You AGEJQ2025-09-17
07630243641253KENDADent4You AGEJQ2025-09-17
07630243641260KENDADent4You AGEJQ2025-09-17
07630243641277KENDADent4You AGEJQ2025-09-17
07630243641284KENDADent4You AGEJQ2025-09-17
07630243641291KENDADent4You AGEJQ2025-09-17
07630243641307KENDADent4You AGEJQ2025-09-17
07630243641314KENDADent4You AGEJQ2025-09-17
07630243641321KENDADent4You AGEJQ2025-09-17
07630243641338KENDADent4You AGEJQ2025-09-17
07630243641345KENDADent4You AGEJQ2025-09-17
07630243641352KENDADent4You AGEJQ2025-09-17
07630243641369KENDADent4You AGEJQ2025-09-17
07630243641376KENDADent4You AGEJQ2025-09-17
07630243641383KENDADent4You AGEJQ2025-09-17
07630243641390KENDADent4You AGEJQ2025-09-17
07630243641420KENDADent4You AGEJQ2025-09-17
07630243641437KENDADent4You AGEJQ2025-09-17