FDA.reportPublic FDA data

Sinfony™

Primary DI
04035077000505
Brand
Sinfony™
Company
3M Deutschland GmbH
Model
49180
Catalog number
49180
Device description
3M™ ESPE™ Sinfony™ Dentin-Material D B3 Shade Dispenser Refill, 49180
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
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035077016162Direct MarkingGS10
04035077000505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035077016162040350770161624035077016162
04035077000505040350770005054035077000505

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, hardA denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

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
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
040545967341423M™ Penta™77944779442026-05-08
040545967342273M™ Penta™76994769942026-05-08
040545967359103M™ Impregum™P31779P317792026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07
07630243601301ParaCoreDent4You AGEBF2026-07-07
07630243634743ParaCoreDent4You AGEBF2026-07-07
07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702947SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02