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Flight Dental Systems Usa Inc.: FDA-registered device maker in Houston, TX, United States, 7 510(k) clearances

Name: Flight Dental Systems Usa Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Flight Dental Systems Usa Inc. is registered with the FDA (registration 3023861999) in Houston, TX, United States. It lists 13 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3023861999
Address: 3103 Farrell Rd, Houston, TX, United States, 77073
Owner or operator: Flight Dental Systems USA Inc. (10091848)
Roles: Repackager or relabeler
First device listed: November 7, 2024
Registered through: 2027
Brand names listed: (6 pins); QC5116KW Quick Connector, 4 holes; QC6016K Quick Connector, 4 holes (6 pins); QC6016KW Quick, 11 Premium Service Oil; LU1022 Premium Service Oil; LU1031 Service Oil;; QC4014K Quick Connector, 4 holes; QC4014NT Quic, 4 holes (6 pins); QC5016KW Quick Connector, 4 holes (6 pins); QC5016NT Quick Connector, 4 holes (6 pins); QC5016SW Quick, A-Series Delivery Unit (A2, A6, A12) A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1300FC, MC-1302F-VAC, MC-1300F-VAC), A-Series Delivery Unit (A2, A6, A12); A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1302F-VAC, MC-1300F-VAC, MC-1300FC);, A12 Radius Operatory, A6 Radius Operatory, A6 Standard Operatory and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Bed, Manual	FNJ	1	Repackager or relabeler	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 6, 2025	K243994	Steam Sterilizer (2545D)	FLE	Substantially Equivalent	Ningbo Ican Machines Co., Ltd.	accessdata.fda.gov
May 26, 2020	K181691	High-speed air turbine handpiece / Low-speed air turbine handpiece	EFB	Substantially Equivalent	Foshan Wenjian Medical Instrument Co., Ltd.	accessdata.fda.gov
March 16, 2018	K172928	Portable X-ray System	EHD	Substantially Equivalent	Rolence Enterprise, Inc.	accessdata.fda.gov
March 19, 2008	K080025	LED.L, LED.M, LED.G, LED.B	EBZ	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
January 26, 2007	K070196	FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT	EIA	Substantially Equivalent	Hr Dental Products, Inc.	accessdata.fda.gov
April 22, 2004	K040396	ULTRASONIC SCALER ELEGANCE MS-10 (25K)	ELC	Substantially Equivalent	Rolence Enteprise, Inc.	accessdata.fda.gov
October 2, 2003	K032234	MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K	EFB	Substantially Equivalent	Mk-Dent GmbH	accessdata.fda.gov

Compare with other makers

Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.