FDA.reportPublic FDA data

CERAMAGE

Primary DI
E23524000
Brand
CERAMAGE
Company
SHOFU DENTAL CORPORATION
Model
2400
Catalog number
2400
Device description
CERAMAGE GUM-SP 5G
Published
2021-02-03
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
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050401000CERAMAGEShofu Dental Corp.2005-04-28EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23524000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)827-5262customer-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
E235DD16A1ML0DENTADISCDD16A1MLDD16A1ML2026-07-09
E235DD16A1MN0DENTADISCDD16A1MNDD16A1MN2026-07-09
E235DD16A2ML0DENTADISCDD16A2MLDD16A2ML2026-07-09
E235DD16A2MN0DENTADISCDD16A2MNDD16A2MN2026-07-09
E235DD16A35MN0DENTADISCDD16A35MNDD16A35MN2026-07-09
E235DD16A3MN0DENTADISCDD16A3MNDD16A3MN2026-07-09
E235DD16B1ML0DENTADISCDD16B1MLDD16B1ML2026-07-09
E235DD16B1MN0DENTADISCDD16B1MNDD16B1MN2026-07-09
E235DD16B2MN0DENTADISCDD16B2MNDD16B2MN2026-07-09
E235DD16B3MN0DENTADISCDD16B3MNDD16B3MN2026-07-09
E235DD16BL1MN0DENTADISCDD16BL1MNDD16BL1MN2026-07-09
E235DD16BL2MN0DENTADISCDD16BL2MNDD16BL2MN2026-07-09
E235DD16BL3ML0DENTADISCDD16BL3MLDD16BL3ML2026-07-09
E235DD16BL4MN0DENTADISCDD16BL4MNDD16BL4MN2026-07-09
E235DD16BLML0DENTADISCDD16BLMLDD16BLML2026-07-09
E235DD16BLMN0DENTADISCDD16BLMNDD16BLMN2026-07-09
E235DD16C1ML0DENTADISCDD16C1MLDD16C1ML2026-07-09
E235DD16C1MN0DENTADISCDD16C1MNDD16C1MN2026-07-09
E235DD16C2ML0DENTADISCDD16C2MLDD16C2ML2026-07-09
E235DD16C2MN0DENTADISCDD16C2MNDD16C2MN2026-07-09

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