BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLIGHT DENTAL SYSTEMS USA INC.

    Reg #: 3023861999 · FEI: 3023861999 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    45
    Establishment Types
    1
    Classifications
    13

    Registration Details

    Registration Name
    FLIGHT DENTAL SYSTEMS USA INC.
    Registration Number
    3023861999
    FEI Number
    3023861999
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3103 Farrell Rd
    City
    Houston
    State
    TX
    ZIP
    77073
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172928

    Owner / Operator

    Firm Name
    Flight Dental Systems USA Inc.
    Operator Number
    10091848
    Address
    3103 Farrell Road
    City
    Houston
    State
    TX
    Postal Code
    77073
    Country
    US
    Correspondent
    Colleen Hui

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    Unit, X-Ray, Extraoral With Timer EHD
    Cleaner, Ultrasonic, Medical Instrument FLG
    Unit, Operative Dental, Accessories NRD
    Activator, Ultraviolet, For Polymerization EBZ
    Chair, Dental, Without Operative Unit NRU
    Unit, Operative Dental EIA
    Light, Operating, Dental EAZ
    Sterilizer, Steam FLE
    Handpiece, Air-Powered, Dental EFB
    Scaler, Ultrasonic ELC
    Bed, Manual FNJ
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    XR-3800, XR-3801, XR-3802 X-Vision Portable Handheld X-Ray SonicArc UC-6032, UC-6065, UC-6100, UC-6220 A-Series Delivery Unit (A2, A6, A12); A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1302F-VAC, MC-1300F-VAC, MC-1300FC); FLIGHT DENTAL SYSTEMS- A-Series (A12, A6S, A2, A10, A6R) X-Cure, Xlite2NEO, VisionCure A6 Radius Operatory A-Series Delivery Unit (A2, A6, A12) A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1300FC, MC-1302F-VAC, MC-1300F-VAC) A6 Standard Operatory A12 Radius Operatory Polaris LED Flight Quantum Surgical Light IRIS LED, Torch LED, iView LED/Camera Steam Sterilizer : Clave8+, Clave16+, Clave18+, Clave23+, Clave28+, Clave45+, ClaveB, Clave45+B Light; HB21K BASIC LINE; HB21KL BASIC LINE High Speed Handpiece with Light; HB23K BASIC LINE High Speed Handpiece; HC21K CLASSIC LINE High Speed Handpiece HC21KL CLASSIC LINE High Speed Handpiece with Light; HC22K CLASSIC LINE; HC22KL CLASSIC LINE High Speed Handpiece with Light; HC8021K PRIME LINE High Speed Handpiece; HE11 ECO LINE; HE12 ECO LINE HE12 ECO LINE High Speed Handpiece; HE14 ECO LINE High Speed Handpiece; HE15L ECO LINE High Speed; (6 pins); QC5116KW Quick Connector, 4 holes; QC6016K Quick Connector, 4 holes (6 pins); QC6016KW Quick High Speed Handpiece with Light; HE22W ECO LINE High Speed Handpiece;; HE22WL ECO LINE High Speed Handpiece Handpiece; HE20K ECO LINE High Speed Handpiece; HE20KL ECO LINE; HE21K ECO LINE High Speed Handpiece High Speed Handpiece with Light; HP22KL PRIME LINE; HP22NL PRIME LINE High Speed Handpiece with Light; 11 Premium Service Oil; LU1022 Premium Service Oil; LU1031 Service Oil;; QC4014K Quick Connector, 4 holes; QC4014NT Quic Connector, 4 holes (6 pins); QC6016NT Quick Connector, 4 holes; QC6016S Quick Connector, 4 holes (6 pins); QC6116K Quick AM0002 Airmotor, 2 holes, 2000 rpm; AM0004 Airmotor, 4 holes, 2000 rpm; AM0012 Airmotor, 2 holes, 2000 rpm; AM0014 rpm; HB12 BASIC LINE High Speed Handpiece; HB14 BASIC LINE High Speed; EM-9001 Electric Motor System and EMB-9002 ECO LINE High Speed Handpiece with Light; HE21W ECO LINE High Speed Handpiece; HE21WL ECO LINE High Speed; Connector, 4 holes; QC4014W Quick Connector, 4 holes; QC5015K Quick Connector, 4 holes QC5016K Quick Connector HB23KL BASIC LINE; HC20K CLASSIC LINE High Speed Handpiece; HC20KL CLASSIC LINE High Speed Handpiece with Light Electric Motor System; HB15L BASIC LINE High Speed Handpiece with Light; HB16L BASIC LINE High Speed Handpiece with Conn HE16L ECO LINE High Speed Handpiece with Light; HE17 ECO LINE High Speed Handpiece; HE17B ECO LINE; HE18 ECO LINE High 4 holes (6 pins); QC5016KW Quick Connector, 4 holes (6 pins); QC5016NT Quick Connector, 4 holes (6 pins); QC5016SW Quick with Light; HP21KL PRIME LINE; HP21NL PRIME LINE High Speed Handpiece with Light; HP21SL PRIME LINE High Speed; HP21WL P Connector, 4 holes (6 pins);; QC5016W Quick Connector, 4 holes (6 pins); QC5116K Quick Connector, 4 holes HE21KL ECO LINE High Speed Handpiece with Light; HE21N ECO LINE High Speed Handpiece; HE21NL ECO LINE High Speed; HE21SL HE22K ECO LINE High Speed Handpiece; HE22KL ECO LINE High Speed Handpiece with Light; HE22N ECO LINE; HE22NL ECO LINE Flight Dental Systems - Ultrasonic Scaler - FMS-2530, BI-2530, N6LED-1902 FMS-2530R2 Flight Hospital Bed Kavo Style Coupler- QC-164K, QC-170K, QC-165K Bold Series Highspeed Handpiece - F-170K, F-160, F-164, F-164T, F-170KT, QC-164K, QC-170, F-140, F-161K, F-162K, F-163K Bold Series Highspeed Handpiece - F-160K F-424BM, F-424BW, F-415BZ, FFB-Y-HEAD, FFB-HEAD, FFB-HEAD, F-541CA, F-411CA, F-DE11, F-DE01, F-DE41, F-DE41PS, F-DE74 F-416BM, F-414BSU, F-434BSUW, F-424BZ, F-L80HEAD, F-L68HEAD

    Establishment Types

    Repack or Relabel Medical Device