FDA.reportPublic FDA data

Impregum™ Penta™ Soft Medium Body

Primary DI
04035077004404
Brand
Impregum™ Penta™ Soft Medium Body
Company
3M Deutschland GmbH
Model
P31735
Catalog number
P31735
Device description
3M™ ESPE™ Impregum™ Penta™ Soft Medium Body Polyether Impression Material Introkit, P31735
Published
2017-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN
EFDAMALGAMATOR, DENTAL, AC-POWERED
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
EFDAmalgamator, Dental, Ac-PoweredDental1
EIDSyringe, Restorative And Impression MaterialDental1
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035077004404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035077004404040350770044044035077004404

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material adhesiveA liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
315731711
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
040640351931573M™ Tegaderm™1624W1624W2026-07-24
040640351931953M™ Tegaderm™1624W1624W2026-07-24
040640351932323M™ Tegaderm™1626W1626W2026-07-24
307073877737323M™ Coban™2094N2094N2026-05-08
307073877737493M™ Coban™2794N2794N2026-05-08
340467190223813M™ Coban™209420942026-05-08
507073878180243M™ Tegaderm™1624WNS1624WNS2026-05-08
507073878180313M™ Tegaderm™1626WNS1626WNS2026-05-08
507073878180483M™ Tegaderm™1628NS1628NS2026-05-08
507073878180553M™ Tegaderm™1688NS1688NS2026-05-08
507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
507073878180793M™ Tegaderm™1683NS1683NS2026-05-08
007073874969683M™CMW06CMW062026-05-08
007073874969753M™CMW04CMW042026-05-08
007073874969823M™CMW03CMW032026-05-08
007073874969993M™CMW02CMW022026-05-08
007073878101223M™ Micropore™1530SS-11530SS-12026-05-08
040467192917003M™ Coban™2794E2794E2026-05-08
040545960049553M™ Coban™209220922026-05-08
040545966458133M™71507715072026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00304040194416Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194423Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194430Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194447Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
07506338322638VIVID JELMDC DENTALELW2026-07-20
07506338322645VIVID JELMDC DENTALELW2026-07-20
07506338322652VIVID JELMDC DENTALELW2026-07-20
07506338322669BLU JELMDC DENTALELW2026-07-20
07506338322676BLU JELMDC DENTALELW2026-07-20
07506338322690VIVID JELMDC DENTALELW2026-07-20
04548162373847AccuMix Ampule MixerSHOFU DENTAL CORPORATIONEFD2026-07-17
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09