FDA.reportPublic FDA data

Smart Dent ®

Primary DI
D14307560147451840
Brand
Smart Dent ®
Company
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.
Model
SMART PRINT BIO VITALITY B1
Catalog number
1266
Device description
Smart Print Bio Vitality is a light-curable resin intended for the fabrication of definitive dental restorations. The material can be used to produce single crowns, veneers, inlays, onlays, and artificial teeth for dental prostheses. It is also suitable for the production of removable definitive full dentures, as well as individual and removable monolithic full and partial dentures in dental offices and laboratories. The product is indicated for anterior and posterior restorations, providing an alternative to conventional restorative materials in both clinical and laboratory settings.
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBIResin, Denture, Relining, Repairing, Rebasing
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260152000Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.2026-04-23EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D14307560147451840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Contacts#

Phone, Email table
PhoneEmail
+551634194735contato@smartdent.com.br

Regulatory Flags#

DUNS number
899849957
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D14307560147448040Smart Dent ®SMART PRINT BIO VITALITY A2-HT22302026-05-29
D14307560147448110Smart Dent ®SMART PRINT BIO VITALITY A3-HT22312026-05-29
D14307560147448280Smart Dent ®SMART PRINT BIO VITALITY BL1-HT22322026-05-29
D14307560147448350Smart Dent ®SMART PRINT BIO VITALITY B1-HT22332026-05-29
D14307560147449650Smart Dent ®SMART PRINT BIO VITALITY A217362026-05-29
D14307560147450090Smart Dent ®SMART PRINT BIO VITALITY BL116442026-05-29
D14307560147450160Smart Dent ®SMART PRINT BIO VITALITY A316452026-05-29
D14307560147451460Smart Dent ®SMART PRINT L'AQUA MODEL 1KG2023-10-23
D14307560147451530Smart Dent ®SMART PRINT L'AQUA MODEL 500g2023-10-23
D14307560147451600Smart Dent ®SMART PRINT L'AQUA MODEL 250g2023-10-23
D14307560147453510Smart Dent ®SMART PRINT PRECISION MODEL 1KG2023-10-23
D14307560147453680Smart Dent ®SMART PRINT PRECISION MODEL 500G2023-10-23
D14307560147453750Smart Dent ®SMART PRINT PRECISION MODEL 250G2023-10-23
D14307560147453820Smart Dent ®SMART PRINT GUM MODEL COLOR PINK 250G 2023-10-23
D14307560147454360Smart Dent ®SMART PRINT BIO CLEAR GUIDE 1KG2023-10-23
D14307560147454430Smart Dent ®SMART PRINT BIO CLEAR GUIDE 250GR 2023-10-23
D14307560147454500Smart Dent ®SMART PRINT BIO CLEAR GUIDE 500G2023-10-23
D14307560147454670Smart Dent ®SMART PRINT BIO CLEAR GUIDE 100G 2023-10-23
D14307560147455800Smart Dent ®SMART PRINT UNIVERSAL MODEL SALMON 100G 2023-10-23
D14307560147455970Smart Dent ®SMART PRINT UNIVERSAL MODEL SALMON 1KG 2023-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29