Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023861999

FEI Number

3023861999

Entity Name

FLIGHT DENTAL SYSTEMS USA INC.

City/State/Country

Houston, TX, US

Establishment Address

3103 Farrell Rd, Houston, TX 77073, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Flight Dental Systems USA Inc. (Owner Number: 10091848)

Owner / Operator Contact Address

3103 Farrell Road, Houston, TX 77073, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040396

PMA Number

N/A

All Registered 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 FLIGHT DENTAL SYSTEMS- A-Series (A12, A6S, A2, A10, A6R) 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2024-11-07
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-11-07
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-06-14
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2024-11-07
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2025-08-29
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2024-11-07
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2024-11-07
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2024-11-07
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2025-06-14
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2024-11-07
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2024-11-07

Official Correspondent

Colleen Hui

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Flight Dental Systems USA Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023861999. Last updated year: 2026. Please use registration number 3023861999 when referencing this establishment in official correspondence.