FDA.reportPublic FDA data

Smart Dent ®

Primary DI
D14307560147454500
Brand
Smart Dent ®
Company
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.
Model
SMART PRINT BIO CLEAR GUIDE 500G
Device description
3D Printing Resin for guide models
Published
2023-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D14307560147454500PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
899849957
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D14307560147448590Smart Dent ®SMART PRINT MODEL PLUS 1kg21702026-07-23
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
D14307560147451840Smart Dent ®SMART PRINT BIO VITALITY B112662026-05-29
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
D14307560147454670Smart Dent ®SMART PRINT BIO CLEAR GUIDE 100G 2023-10-23
D14307560147455800Smart Dent ®SMART PRINT UNIVERSAL MODEL SALMON 100G 2023-10-23

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