BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NUSMILE, LTD

    Reg #: 3006444232 · FEI: 3006444232 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    92
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    NUSMILE, LTD
    Registration Number
    3006444232
    FEI Number
    3006444232
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3315 W 12th St
    City
    HOUSTON
    State
    TX
    ZIP
    77008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201993

    Owner / Operator

    Firm Name
    NUSMILE, LTD
    Operator Number
    9106343
    Address
    3315 W. 12th, --
    City
    Houston
    State
    TX
    Postal Code
    77008
    Country
    US
    Correspondent
    DIANE JOHNSON KRUEGER

    Products

    Device Name Product Code
    Locator, Root Apex LQY
    Handpiece, Direct Drive, Ac-Powered EKX
    File, Pulp Canal, Endodontic EKS
    Crown, Preformed ELZ
    Liner, Cavity, Calcium Hydroxide EJK
    Resin, Root Canal Filling KIF
    Cement, Dental EMA
    Diammine Silver Fluoride Dental Hypersensitivity Varnish PHR
    Gauge, Depth, Instrument, Dental EIL
    Plier, Orthodontic JEX
    Cleanser, Root Canal KJJ
    Instruments, Dental Hand DZN
    Sealant, Pit And Fissure, And Conditioner EBC
    Cutter, Wire HXZ
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Point, Paper, Endodontic EKN
    Varnish, Cavity LBH
    Plugger, Root Canal, Endodontic EKR
    Maintainer, Space Preformed, Orthodontic DYT
    Gutta-Percha EKM
    Scissors, Surgical Tissue, Dental EGN
    Bur, Surgical, General & Plastic Surgery GFF

    Proprietary Names

    Avalon Biomed by ZARC Z-Evo Excalibur File BlueShaper PRO FIle NanoShaper File SlimShaper PRO File Z-Condensor File ApicalShaper File SlimShaper File BlueShaper File Excalibur Glider PRO File Excalibur PRO Mini File RetreatAll File Z-Glider File Z-Glider Evo File Z-Plugger NuSmile Pre-Contoured Stainless Steel Crowns (SSC) NuSmile Pediatric Crowns NuSmile Signature Crowns NuSmile Zirconia (ZR) Crowns NuSmile BioFlx Crowns NuSmile ReVIVE Crowns NeoLINER Avalon Biomed NeoMTA 2 NuSmile NeoMTA 2 MTA 2.3.1 NuSmile NeoMTA ES Zarc NeoMTA 2 Bioceramic Reparative Cement by Avalon Biomed NuSmile NuCem Avalon Biomed Silver Diamine Fluoride (SDF) NuSmile NuNamel Silver Diamine Fluoride (SDF) Z-Ruler File Organizer, Autoclavable Ruler Endo-Block Ruler Z-Guage Ruler NuSmile Tube Crimping Plier NuSmile Bird Beak Plier NuSmile 3 Jaw Plier NuSmile Band / Crown Crimping Plier NuSmile Contouring Plier Avalon Biomed NeoSolv NuSmile Bite Stick / Band Seater - White NuSmile Posterior Band Remover NuSmile Heavy Band Pusher NuSmile NuNamel Sealant NuSmile Hard Wire Cutter Avalon Biomed NeoPUTTY NuSmile NeoPUTTY Avalon Biomed NeoSEALER Flo Avalon Biomed NeoSEALER EZFlo Avalon Biomed NeoSEALER Flex Flo Tips Avalon Biomed NeoSEALER Flo tips Avalon Biomed NeoSEALER Flo Basic Flex Tips Avalon Biomed Basic Flex Tips Avalon Biomed Navi TIps Avalon Biomed Clear Flex Tips Z-Rinse NuSmile NuNamel Brush Tips NanoShaper Paper Point Excalibur Mini Paper Point ApicalShaper Paper Point Excalibur Paper Point Z-Fit Paper Point Zarc Paper Point SlimShaper Paper Point Zarc Fine Paper Point BlueShaper Paper Point Zarc X-Fine Paper Point NuSmile NuNamel Varnish NuSmile NeoMTA Avalon Biomed NeoMTA Plus Z-DOWN System Z Micro-Shaper Z Micro-Opener Z-UP System NuSmile BioCem Chairside Space Maintainer Zarc Fine Gutta-Percha BlueShaper Gutta-Percha NanoShaper Gutta-Percha Z-Fit Gutta-Percha SlimShaper Gutta-Percha ApicalShaper Gutta-Percha Zarc X-Fine Gutta-Percha Excalibur Mini Gutta-Percha Zarc Gutta-Percha Excalibur Gutta-Percha NuSmile Silver Diamine Fluoride (SDF) NuSmile Heavy Curved Scissors NuSmile Preparation Bur NuSmile Signature Adjustment Bur NuSmile ZR Adjustment Bur Avalon Biomed Grey MTA Plus

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device