FDA.reportPublic FDA data

3M™ Sof-Lex™

Primary DI
30605861059177
Brand
3M™ Sof-Lex™
Company
3M COMPANY
Model
5091
Catalog number
5091
Device description
3M™ Sof-Lex™ Diamond Polishing Spiral, 5091
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
50605861059171PackageGS110In Commercial Distribution
30605861059177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060586105917150605861059171
3060586105917730605861059177

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
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
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