BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    LABORATORIOS DENTALES DE ZONA FRANCA, S.A.

    Reg #: 3001295407 · FEI: 3001295407 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    153
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    LABORATORIOS DENTALES DE ZONA FRANCA, S.A.
    Registration Number
    3001295407
    FEI Number
    3001295407
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ENTRADA A HIGUITO, SAN ISIDRO DEL GUARCO
    City
    CARTAGO
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K191222

    Owner / Operator

    Firm Name
    LABORATORIOS DENTALES DE ZONA FRANCA, S.A
    Operator Number
    9012389
    Address
    ENTRADA A HIGUITO, SAN ISIDRO DEL GUARCO
    City
    CARTAGO
    State
    CR-C
    Postal Code
    30802
    Country
    CR
    Correspondent
    Michelle - Gallup

    Products

    Device Name Product Code
    Prosthesis, Orthodontic NSR
    Dentures, Full NSL
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Dentures, Partial NSK
    Instruments, Dental Hand DZN
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC
    Restoration, Resin, Crown And Bridge NSN
    Device, Anti-Snoring LRK
    Restoration, Noble Metal NSJ
    Restoration, Porcelain-Fused-To-Metal NSO
    Restoration, Porcelain NSP
    Restoration, Base Metal NSQ
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Orthodontic Prosthesis Full Dentures Custom Abutment - Astra EV Custom Abutment - Straumann BLX Custom Abutment - Hahn Gold Custom Abutment Acrylic/flexible partials Duplication stent Custom Abutment - Ankylos Comfort™ 3D Bite Splint Custom Abutment - Nobel Replace Custom Abutment - 3i Certain Custom Abutment - Zimmer TSV Premise Indicrect Inlays/Onlays/Crown/Post/Wing/Veneer Elastic Mandibular Advancement (EMA) appliance Yellow Gold Metal Crown Foundation Bridge Semi-Precious Post in Crown Full Cast 50 Crown OcclusalGold Metal Crown Foundation Full Cast Yellow Noble Inlay/Onlay Crown White High Noble Post in Crown Semi-Precious Metal Crown Foundation White Gold Metal Crown Foundation Yellow High Noble Crown Foundation White High Noble Crown Foundation Jrvt Gold Crown Semi-Precious Crown Foundation Noble Restoration Crown/Substructure/Inlay/Onlay Yellow Noble Crown Foundation Semi-Precious Metal Crown Foundation Bridge Jrvt Gold Inlay/Onlay Crown Full Cast White High Noble Crown Full Yellow High Noble Gold Crown Captek Crown Foundation Captek Crown Foundation Bridge Yellow High Noble Post in Crown Yellow Gold Metal Crown Foundation Full Cast Semi-Precious Inlay/Onlay Crown Full Cast Semi-Precious Crown White Gold Metal Crown Foundation Bridge Full Cast Galileo Crown Telescopic Coping - Metal Coping Captek Coping OcclusalGold Metal Crown Foundation Bridge Full Cast Yellow Gold Crown Full Cast Yellow High Noble Gold Inlay/Onlay Crown Noble Metal Restoration Silent Nite sl Custom Abutment - Hiossen Custom Abutment - Megagen Porcelain Fused to Gold Crown Foundation Bridge Sculpture Fused to Non - Precious Crown Porcelain to Semi-Precious Metal Crown Bridge Porcelain to Semi-Precious Metal Occlusal Crown Bridge Porcelain to Non-Precious Metal Unfinished Crown Sculpture Fused to Semi - Precious Crown Porcelain Fused to White High Noble Crown Bridge Porcelain Fused to Gold Crown Bridge Open Face Gold Crown PF to White High Noble Metal Occlusal Crown Bridge Porcelain to Non-Precious Metal Occlusal Crown Porcelain Fused to Gold with Metal Occlusal Crown Bridge Porcelain to Semi-Precious Metal Crown Porcelain Fused to Gold with Metal Occlusal Crown Porcelain to Semi-Precious Metal Unfinished Crown Captek Unfinished Crown Captek Crown Bridge Porcelain Fused to White High Noble Metal Occlusal Crown Porcelain Fused to White High Noble Crown Captek Crown Porcelain to Semi-Precious Metal Occlusal Unfinished Crown Porcelain Fused to Gold Crown Porcelain to Non-Precious Metal Crown Bridge PF to White High Noble Metal Occlusal Unfinished Crown Sculpture Fused to White High Noble Crown Porcelain to Non-Precious Metal Crown Porcelain to Non-Precious Metal Occlusal Unfinished Crown Porcelain Fused to Gold Crown Foundation Porcelain Fused to Gold with Metal Occlusal Unfinished Crown Porcelain Fused to Gold Unfinished Crown Porcelain to Semi-Precious Metal Occlusal Crown Porcelain Fused to White High Noble Unfinished Crown Porcelain to Non-Precious Metal Occlusal Crown Bridge Sculpture Fused to Yellow High Noble Crown Porcelain Fused to Base metal or Noble Restoration Crown/Bri Porcelain-Fused-To-Metal Restoration Obsidian Porcelain Fused to White High Noble - Crown/Bridge, Inlay/Onlay Obsidian Porcelain Fused to Non-Precious Metal - Crown/Bridge, Inlay/Onlay Obsidian Porcelain Fused to Semi-Precious Metal - Crown/Bridge, Inlay/Onlay Custom Abutment - Branemark Custom Abutment - Nobel Active Custom Abutment - Straumann Bone Level Custom Abutment - Straumann SynOcta Custom Abutment - Camlog Thermoforming Nightguard/Mouthguard/Bleaching Tray Camouflage - Crown/Bridge, Inlay/Only, Veneer Cercon Crown Prismatik Clinical Zirconia Crown No Prep Veneer Cercon Crown Substructure Empress Crown Emax Crown Empress Esthetic Crown Cercon Unfinished Crown Emax Veneer Porcelain Fused to Generic Zirconia Crown/Substructure Porcelain Fused to Generic Zirconia Crown Substructure BruxZir Full Contour Zirconia Milled Crown Emax Inlay/Onlay Crown Empress Unfinished Inlay Crown BruxZir Zirconia Unfinished Crown Emax Unfinished Crown Sculpture Crown Empress Esthetic Crown/Veneer/Inlay/Onlay Emax Veneer/Crown/Inlay/Onlay Prismatik Clinical Zirconia Crown/Substructure Sculpture Inlay/Onlay Crown Empress Unfinished Crown Porcelain Fused to Generic Zirconia Crown Emax Crown Substructure Sculpture Veneer BruxZir Full Contour Zirconia Milled Crown Bridge Sculpture Crown/Wing/Substructure/Inlay/Onlay/Splint/Veneer Porcelain Fused to Generic Zirconia Unfinished Crown Sculpture Lingual Splint Crown Sculpture Crown Foundation Empress Inlay/Onlay Crown Prismatik Clinical Zirconia Crown Substructure BruxZir Full Contour Zirconia Crown Empress Esthetic Veneer BruxZir Full Contour Zirconia Inlay/Onlay Crown Open Face in Sculpture Crown BruxZir Full Contour Zirconia Unfinished Crown Bridge Empress Veneer Empress Unfinished Veneer Sculpture Wing Crown Emax Unfinished Veneer Cercon Crown/Substructure BruxZir Full Contour Zirconia Crown Bridge BruxZir Full Contour Zirconia Crown/Bridge/Inlay/Onlay BruxZir Full Arch Implant Prosthesis Temporary Crown Restoration BruxZir Esthetic - Crown/Bridge, Inlay/Onlay, Veneer Custom Abutment - Astra Non-Precious Crown Foundation Non-Precious Metal Crown Foundation Bridge Full Cast Non-Precious Inlay/Onlay Crown Non-Precious Post in Crown Full Non-Precious Crown Non-Precious Metal Crown Foundation Base Metal Restoration Crown/Substructure/Inlay/Onlay Surgical Guide Custom Abutment - Biohorizons

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)