FDA.reportPublic FDA data

BEAUTIBOND UNIVERSAL

Primary DI
E235Y24400
Brand
BEAUTIBOND UNIVERSAL
Company
SHOFU DENTAL CORPORATION
Model
Y2440
Catalog number
Y2440
Device description
BEAUTIBOND UNIVERSAL ADHESIVE 6 ML
Published
2021-02-03
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172530000BEAUTIFIL Flow Plus XShofu Dental Corporation2017-12-06EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235Y24400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-827-4923customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548162373847AccuMix Ampule MixerE0006E00062026-07-17
E235P08380VINTAGE PRIME PRESSP0838P08382026-07-17
E235P08390VINTAGE PRIME PRESSP0839P08392026-07-17
E235P08580VINTAGE PRIME PRESSP0858P08582026-07-17
E235P08590VINTAGE PRIME PRESSP0859P08592026-07-17
E235P08610VINTAGE PRIME PRESSP0861P08612026-07-17
E235P08620VINTAGE PRIME PRESSP0862P08622026-07-17
E235P08630VINTAGE PRIME PRESSP0863P08632026-07-17
E235P08640VINTAGE PRIME PRESSP0864P08642026-07-17
E235P08650VINTAGE PRIME PRESSP0865P08652026-07-17
E235P08660VINTAGE PRIME PRESSP0866P08662026-07-17
E235P08670VINTAGE PRIME PRESSP0867P08672026-07-17
E235P08680VINTAGE PRIME PRESSP0868P08682026-07-17
E235P08690VINTAGE PRIME PRESSP0869P08692026-07-17
E235P08710VINTAGE PRIME PRESSP0871P08712026-07-17
E235P08720VINTAGE PRIME PRESSP0872P08722026-07-17
E235P08730VINTAGE PRIME PRESSP0873P08732026-07-17
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591676DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591720DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591911DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
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