Manufacturer registered with FDA

Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

SAO CARLOS, Brazil. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10088568Manufacturer1 clearance in five years
Device types listed
5
Brands and models
45
510(k) clearances
12026–2026
Markets registered in
21 registrations outside the US
Establishments
1Brazil
2026: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. as the manufacturer or the registration holder of a device.

All markets
United States: 5 device types listedCosta Rica: 1 registrations
RegisteredHome: BrazilOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMmtech Projetos Tecnologicos Importacao E Exportacao Ltda.1 clearances2026–2026Below
Costa RicaMinisterio de SaludManufacturerMMTech Projetos Tecnológicos Importação e Exportação Ltda.1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
SMART PRINT BIO VITALITY A2SMART PRINT BIO VITALITY A2-HTSMART PRINT BIO VITALITY A3SMART PRINT BIO VITALITY A3-HTSMART PRINT BIO VITALITY B1SMART PRINT BIO VITALITY B1-HTSMART PRINT BIO VITALITY BL1SMART PRINT BIO VITALITY BL1-HT
2026
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker
SMART PRINT GUM MODEL COLOR PINK 250gSMART PRINT L'AQUA MODEL 1kgSMART PRINT L'AQUA MODEL 250gSMART PRINT L'AQUA MODEL 500gSMART PRINT MODEL PLUS 1kgSMART PRINT OCHER MODEL 1kgSMART PRINT OCHER MODEL 250gSMART PRINT OCHER MODEL 500gSMART PRINT PRECISION MODEL 1kgSMART PRINT PRECISION MODEL 250g
7 more
SMART PRINT PRECISION MODEL 500gSMART PRINT TRY-IN CASTABLE 1kgSMART PRINT TRY-IN CASTABLE 250gSMART PRINT UNIVERSAL MODEL SALMON 100gSMART PRINT UNIVERSAL MODEL SALMON 1kgSMART PRINT UNIVERSAL MODEL SALMON 250gSMART PRINT UNIVERSAL MODEL SALMON 500g
2023
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethMaker
SMART PRINT BIO VITALITY A2SMART PRINT BIO VITALITY A2-HTSMART PRINT BIO VITALITY A3SMART PRINT BIO VITALITY A3-HTSMART PRINT BIO VITALITY B1SMART PRINT BIO VITALITY B1-HTSMART PRINT BIO VITALITY BL1SMART PRINT BIO VITALITY BL1-HT
2026
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
SMART PRINT BIO CLEAR GUIDE 100gSMART PRINT BIO CLEAR GUIDE 1kgSMART PRINT BIO CLEAR GUIDE 250gSMART PRINT BIO CLEAR GUIDE 500g
2023
Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2Denture resins & teethMaker
SMART PRINT BIO VITALITY A2SMART PRINT BIO VITALITY A2-HTSMART PRINT BIO VITALITY A3SMART PRINT BIO VITALITY A3-HTSMART PRINT BIO VITALITY B1SMART PRINT BIO VITALITY B1-HTSMART PRINT BIO VITALITY BL1SMART PRINT BIO VITALITY BL1-HT
2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. as the applicant.

Decided510(k)DeviceDevice type
23 Apr 2026K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)EBF Resin Tooth Shade Material

Registered establishments

EstablishmentLocationWhat it does
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.FDA reg. 3027526455SAO CARLOS Sao Paulo, BrazilManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10088568). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.