Registered with FDA
Flight Dental Systems USA Inc.
Houston, TX, United States. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 50
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Flight Dental Systems USA Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | AM0002 Airmotor, 2 holes, 2000 rpm; AM0004 Airmotor, 4 holes, 2000 rpm; AM0012 Airmotor, 2 holes, 2000 rpm; AM0014Bold Series Highspeed Handpiece - F-160KBold Series Highspeed Handpiece - F-170K, F-160, F-164, F-164T, F-170KT, QC-164K, QC-170, F-140, F-161K, F-162K, F-163KCLASSIC LINE High Speed Handpiece with Light; HC8021K PRIME LINE High Speed Handpiece; HE11 ECO LINE; HE12 ECO LINEConnConnector, 4 holes (6 pins); QC6016NT Quick Connector, 4 holes; QC6016S Quick Connector, 4 holes (6 pins); QC6116K QuickConnector, 4 holes (6 pins);; QC5016W Quick Connector, 4 holes (6 pins); QC5116K Quick Connector, 4 holesConnector, 4 holes; QC4014W Quick Connector, 4 holes; QC5015K Quick Connector, 4 holes QC5016K Quick ConnectorECO LINE High Speed Handpiece with Light; HE21W ECO LINE High Speed Handpiece; HE21WL ECO LINE High Speed;Electric Motor System; HB15L BASIC LINE High Speed Handpiece with Light; HB16L BASIC LINE High Speed Handpiece with 18 moreF-416BM, F-414BSU, F-434BSUW, F-424BZ, F-L80HEAD, F-L68HEADF-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-DE74Handpiece; HE20K ECO LINE High Speed Handpiece; HE20KL ECO LINE; HE21K ECO LINE High Speed HandpieceHB23KL BASIC LINE; HC20K CLASSIC LINE High Speed Handpiece; HC20KL CLASSIC LINE High Speed Handpiece with LightHC21K CLASSIC LINE High Speed Handpiece HC21KL CLASSIC LINE High Speed Handpiece with Light; HC22K CLASSIC LINE; HC22KLHE12 ECO LINE High Speed Handpiece; HE14 ECO LINE High Speed Handpiece; HE15L ECO LINE High Speed;HE16L ECO LINE High Speed Handpiece with Light; HE17 ECO LINE High Speed Handpiece; HE17B ECO LINE; HE18 ECO LINE HighHE21KL ECO LINE High Speed Handpiece with Light; HE21N ECO LINE High Speed Handpiece; HE21NL ECO LINE High Speed; HE21SLHE22K ECO LINE High Speed Handpiece; HE22KL ECO LINE High Speed Handpiece with Light; HE22N ECO LINE; HE22NL ECO LINEHigh Speed Handpiece with Light; HE22W ECO LINE High Speed Handpiece;; HE22WL ECO LINE High Speed HandpieceHigh Speed Handpiece with Light; HP22KL PRIME LINE; HP22NL PRIME LINE High Speed Handpiece with Light;Kavo Style Coupler- QC-164K, QC-170K, QC-165KLight; HB21K BASIC LINE; HB21KL BASIC LINE High Speed Handpiece with Light; HB23K BASIC LINE High Speed Handpiece;rpm; HB12 BASIC LINE High Speed Handpiece; HB14 BASIC LINE High Speed; EM-9001 Electric Motor System and EMB-9002with Light; HP21KL PRIME LINE; HP21NL PRIME LINE High Speed Handpiece with Light; HP21SL PRIME LINE High Speed; HP21WL P(6 pins); QC5116KW Quick Connector, 4 holes; QC6016K Quick Connector, 4 holes (6 pins); QC6016KW Quick11 Premium Service Oil; LU1022 Premium Service Oil; LU1031 Service Oil;; QC4014K Quick Connector, 4 holes; QC4014NT Quic4 holes (6 pins); QC5016KW Quick Connector, 4 holes (6 pins); QC5016NT Quick Connector, 4 holes (6 pins); QC5016SW Quick | 2024 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Lister | Flight Quantum Surgical LightIRIS LED, Torch LED, iView LED/CameraPolaris LED | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | X-Cure, Xlite2NEO, VisionCure | 2025 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Bold Series Highspeed Handpiece - F-160KBold Series Highspeed Handpiece - F-170K, F-160, F-164, F-164T, F-170KT, QC-164K, QC-170, F-140, F-161K, F-162K, F-163KF-416BM, F-414BSU, F-434BSUW, F-424BZ, F-L80HEAD, F-L68HEADF-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-DE74Kavo Style Coupler- QC-164K, QC-170K, QC-165K | 2024 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | X-Vision Portable Handheld X-RayXR-3800, XR-3801, XR-3802 | 2024 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Lister | A-Series Delivery Unit (A2, A6, A12) A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1300FC, MC-1302F-VAC, MC-1300F-VAC)A12 Radius OperatoryA6 Radius OperatoryA6 Standard Operatory | 2024 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Flight Dental Systems - Ultrasonic Scaler - FMS-2530, BI-2530, N6LED-1902FMS-2530R2 | 2024 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | X-Vision Portable Handheld X-RayXR-3800, XR-3801, XR-3802 | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | 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) | 2024 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | FLIGHT DENTAL SYSTEMS- A-Series (A12, A6S, A2, A10, A6R) | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Flight Dental Systems USA Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Foshan Wenjian Medical Instrument Co., Ltd. (1), Rolence Enterprise, Inc. (1), Guilin Woodpecker Medical Instrument Co., Ltd. (1), Hr Dental Products, Inc. (1), Rolence Enteprise, Inc. (1), MK-dent GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 May 2020 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 16 Mar 2018 | K172928 | Portable X-ray System | Rolence Enterprise, Inc. | EHD Extraoral with Timer X-Ray Unit |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 26 Jan 2007 | K070196 | FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT | Hr Dental Products, Inc. | EIA Operative Dental Unit |
| 22 Apr 2004 | K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | Rolence Enteprise, Inc. | ELC Ultrasonic Scaler |
| 2 Oct 2003 | K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K | MK-dent GmbH | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FLIGHT DENTAL SYSTEMS USA INC.FDA reg. 3023861999 | Houston, TX, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091848). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.