FDA.reportPublic FDA data

Smart Dent ®

Primary DI
D14307560147448590
Brand
Smart Dent ®
Company
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.
Model
SMART PRINT MODEL PLUS 1kg
Catalog number
2170
Device description
Smart Print Model Plus is a light-curing resin intended for the additive manufacturing of dental working and presentation models using compatible DLP/LCD 3D printing systems. The material is supplied as a ready-to-use liquid resin for the fabrication of dental models for use in dental laboratory procedures. The printed models are intended exclusively for extraoral use. Smart Print Model Plus is intended exclusively for professional use.
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D14307560147448590PrimaryHIBCC0

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
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09
00840456223727JMUJMU DENTAL, INCEBH2026-07-09