Registered with FDA
Wuxi Lyusmile Imp and Exp Co.,ltd
WUXI, China. Lists 54 dental device types with FDA across 1 registered establishment.
- Device types listed
- 54
- Brands and models
- 213
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Wuxi Lyusmile Imp and Exp Co.,ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | AIR WATER SYRINGE TIPDENTAL SALIVA EJECTORDENTAL SUCTION TIPsaliva ejectorsuction tubesurgical aspirator tip | 2023 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | DENTAL DRILLFIBER POST DRILLINTRAL ORAL TIP | 2023 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | BUCCAL TUBEorthodontic tube | 2024 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | dental irrigation needleDENTAL NEEDLEdental needle tip with brushDISPOSABLE DENTAL NEEDLEendo irrigation needlemicro prebent needle tipprebent needle tip | 2021 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | dental instrument | 2021 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | BUR HOLDERBUR RETAINER CASEMETAL BURS HOLDERPLASTIC HOLDER | 2023 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | autoclavable mouth mirrordental mouth mirrordisposable mouth mirrormouth mirror with scale | 2021 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Lister | DENTAL LIGHTled curing light | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | metal impression trayrotary impression tray | 2021 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Lister | dental suctiondental unit | 2021 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | AIR WATER SYRINGEAIR WATER SYRINGE COVERAIR WATER SYRINGE TIP | 2021 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | dental elastic.dental Speparatorligature tieNatural ElasticPower Chain | 2021 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | ARTICULATING ARMLIGATURE TIE GUNORTHODONTIC CLAMP | 2023 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | DENTAL ALIGNERinvisable bracketorthodontic bracket | 2021 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | dental rubber dam framePLASTIC RUBBER DAM FRAMERUBBER DAM CLAMPrubber dam kitRUBBER MOUTH SUPPORT | 2023 |
| Articulation PaperEFH · Class 1 | — | Lister | articulating paper | 2021 |
| Roll CottonEFN · Class 1 | — | Lister | COTTON ROLLSDENTAL COTTON ROLLSdental gauzeNON WOVEN SPONGE | 2021 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | denture brushorthodontic brushORTHODONTIC KITtoothbrush | 2021 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | DENTAL WAXORTHODONTIC WAX | 2021 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | digital sensor holderDigital sensor PositionerFilm Positioning System CompleteImaging Plate Barrier Envelopersposition armposition ringSimple X-Ray Film HolderX-ray Film BagX-ray Film HolderX-ray Film Mounts-Clip On 2 moreX-ray Film Washer ClipX-RAY Positioner | 2021 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | dental prophy brushDISPOSABLE PROPHY BRUSHPOLISHING BRUSHprophy angleprophy brushprophy brush kitprophy cup | 2023 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | DENTAL POLISHING STRIPResin polishing stripsSS POLISHING STRIPsteel-STRIPROLL-RESIN | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | ABS IMPRESSION TRAYFLUORIDE FOAM TRAYImpression Bite Begistration Trayimpression trayINSTRUMENT RETAINER TRAYMETAL IMPRESSION TRAYPLASTIC IMPRESSION TRAYstainless steel impression tray | 2023 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | DENTAL EVACUATORDENTAL EVACUATOR TIP | 2023 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | dental rubber damRUBBER DAM | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | CHEEK RETRACTORrubber dam cheek retractorRUBBER MOUTH SUPPORTtongue protector | 2021 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | DENTAL GAUGEENDO FILE RULERENDO GAUGEORTHODONTIC GAUGE | 2023 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | DENTAL EXAMINATION KITDENTAL INSTRUMENT KITDENTAL PROBEDISPOSABLE PROBE | 2021 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | Amalgam CarrierBLEACHING PEN WITH BRUSHBlue white with Mixing wellCarbinet TrayComposite Dispensing Guncomposite mixing boxCotton Pellets DispenserCotton roll dispensorCotton rolls holderCup Dispenser 33 moreDappen DishesDental Barrier Film DispenserDental intraoral positioning plateDENTAL SLEEVEDENTAL SUTURE PRACTICE KITDental Veneering Cleaning BoxDENTAL WEDGEDenture bath boxDisposable Trapsendo file cleanerendo file countingendo file STOPPERFACE MASK HOLDERGauze Sponges Holdergermicide trayGLOVE HOLDERinstruments code ringsIsolator Cotton Rolls HolderMicro Brush DispenserMixing BowlMixing cupNeaten Case,Ortho Study Model MoldsPhotography Contrastplastic cupPlastic Dappen DishesPLASTIC MIXING WELLplastic trayPLASTIC WEDGESpatula,SUTURE PRACTICE PADTEETH MODELTeeth model MIRROR | 2021 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | rubber dam frame | 2023 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | DENTAL ORTHODONTIC BRACKET | 2023 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | rubber dam forcepsRUBBER DAM KIT | 2023 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | DENTAL ALLOY | 2023 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Lister | dental irrigation syringeDental SyringesDisposable Dental SyringesLuer Lock Syringe12cc utility syringe | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | dental carbide burdental carbide cutterdental diamond bursdental diamond discdental discdental polisherdental white stone | 2023 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | BRASS ARTICULATORDisposable ArticulatorPLASTIC ARTICULATORZin Articulator | 2023 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Lister | matrix band | 2021 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | ENDO FILESPREADER FILE | 2021 |
| Endodontic Silver PointEKL · Class 1 | — | Lister | ENDO FILE | 2023 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | dental gutta percha pointGUTTA CUTTERgutta percha point | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | Absorbent Paper Pointspaper point | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | ENDO FILE | 2021 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Lister | DENTAL INSTRUMENT | 2021 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | dental aligner removal hookDENTURE BOXELASTIC PLACERplastic retainer caseprimary denture box | 2024 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | ENDO POST PINfiber postFIBER POST KIT | 2021 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | EUGENOLZINC OXIDE EUGENOL | 2021 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | DENTAL MATRIX BANDDENTAL MATRIX HOLDERDENTAL MATRIX RETAINERIvory Matrix BandsMatrix band with retainer,MATRIX KITmatrix sheetsPlastic matrix bands | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | DENTAL FLOSS | 2021 |
| Tube Impression and MatrixKCQ · Class 1 | — | Lister | MATRIX KIT | 2023 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | saliva ejector | 2021 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | FLUORIDE FOAM TRAY | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | DENTAL IMPLANT KITDENTAL IMPLNAT IRRIGATION KITIMPLANT PROTECTION KIT | 2023 |
| Over the Counter Wax Impregnated Cotton Denture Pad CushionNKJ · Class 1 | — | Lister | dental wax | 2021 |
| Prescription Denture CleanserNUX · Class 1 | — | Lister | denture brushdenture cleaner | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WUXI LYUSMILE IMP AND EXP CO.,LTDFDA reg. 3021023132 | WUXI Jiangsu, China | Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10082225). 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.