Wuxi Lyusmile IMP AND EXP Co., Ltd.
Registered establishment in Wuxi, Jiangsu, China. 66 device types.
Wuxi Lyusmile IMP AND EXP Co., Ltd. is a private-label distributor holding a current FDA establishment registration. The registration covers Bur, Dental, Cover, Cast and 64 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | WUXI LYUSMILE IMP AND EXP CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021023132 |
| FEI number | 3021023132 |
| Establishment type | Private-label distributor |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | Suite 2509, No.990,Western Jianghai Rd. |
| Postal code | 214073 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | saliva ejector | 2021 | 86 |
| Accessories, Implant, Dental, Endosseous | Class 1 | Implant Protection KIT, Dental Implant KIT, Dental Implnat Irrigation KIT | 2023 | 70 |
| Accessories, Retractor, Dental | Class 1 | Rubber Mouth Support, rubber dam cheek retractor, Cheek Retractor, tongue protector | 2021 | 37 |
| Aligner, Bracket, Orthodontic | Class 1 | orthodontic bracket, invisable bracket, Dental Aligner | 2021 | 30 |
| Alloy, Metal, Base | Class 2 | Dental Alloy | 2023 | 24 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Bendable Brush Applicator, Micro Applicator, Composite Brush, Valustick Sticky Applicators, Micro Brush, Cotton Applicator and 1 more | 2021 | 186 |
| Articulators | Class 1 | Disposable Articulator, Zin Articulator, Brass Articulator, Plastic Articulator | 2023 | 7 |
| Band, Elastic, Orthodontic | Class 1 | Power Chain, Natural Elastic, dental Speparator, ligature tie, dental elastic. | 2021 | 36 |
| Blade, Scalpel | Class 1 | Dental Blade, Surgical Blade | 2021 | 41 |
| Bracket, Metal, Orthodontic | Class 1 | Dental Orthodontic Bracket | 2023 | 52 |
| Bur, Dental | Class 1 | dental carbide cutter, dental diamond disc, dental polisher, dental white stone, dental disc, dental diamond burs and 1 more | 2023 | 46 |
| Clamp, Rubber Dam | Class 1 | dental rubber dam frame, rubber dam kit, Plastic Rubber DAM Frame, Rubber Mouth Support, Rubber DAM Clamp | 2023 | 4 |
| Clamp, Wire, Orthodontic | Class 1 | Orthodontic Clamp, Ligature TIE GUN, Articulating ARM | 2023 | 27 |
| Cleanser, Denture, Prescription | Class 1 | denture brush, denture cleaner | 2021 | 3 |
| Cotton, Roll | Class 1 | Dental Cotton Rolls, Cotton Rolls, NON Woven Sponge, dental gauze | 2021 | 107 |
| Cover, Cast | Class 1 | Lead Apron, x-ray Lead Apron, dental sleeve | 2021 | 31 |
| Cup, Prophylaxis | Class 1 | Disposable Prophy Brush, prophy angle, prophy cup, prophy brush, Polishing Brush, prophy brush kit and 1 more | 2023 | 49 |
| Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | Class 1 | dental wax | 2021 | 6 |
| Dam, Rubber | Class 1 | Rubber DAM, dental rubber dam | 2023 | 23 |
| Denture, Plastic, Teeth | Class 2 | dental aligner removal hook, primary denture box, plastic retainer case, Elastic Placer, Denture BOX | 2024 | 26 |
| Device, Digital Image Storage, Radiological | Class 1 | Barrier Envelope, IP BAG | 2021 | 6 |
| Dress, Surgical | Class 1 | Dental Isolation Gown, dental lab gown, Surgical Gown | 2021 | 71 |
| Drill, Dental, Intraoral | Class 1 | Dental Drill, Intral Oral TIP, Fiber Post Drill | 2023 | 20 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | electric wax knife, micro motor, dental vibrator, Alginate impression MIXER, Dental Stone SAW, Techincian Tools Series and 13 more | 2021 | 72 |
| Evacuator, Oral Cavity | Class 1 | Dental Evacuator TIP, Dental Evacuator | 2023 | 49 |
| File, Pulp Canal, Endodontic | Class 1 | Endo File | 2021 | 53 |
| Floss, Dental | Class 1 | Dental Floss | 2021 | 151 |
| Forceps, Rubber Dam Clamp | Class 1 | Rubber DAM KIT, rubber dam forceps | 2023 | 7 |
| Frame, Rubber Dam | Class 1 | rubber dam frame | 2023 | 7 |
| Gauge, Depth, Instrument, Dental | Class 1 | Dental Gauge, Endo File Ruler, Orthodontic Gauge, Endo Gauge | 2023 | 10 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Dental Gauze | 2021 | 266 |
| Gutta-Percha | Class 1 | Gutta Cutter, dental gutta percha point, gutta percha point | 2023 | 42 |
| Holder, Film, X-Ray | Class 1 | Digital sensor Positioner, X-ray Film Washer Clip, X-ray Film Bag, digital sensor holder, position ring, Simple X-Ray Film Holder and 6 more | 2021 | 40 |
| Instrument, Contouring, Matrix, Operative | Class 1 | matrix band | 2021 | 10 |
| Instrument, Diamond, Dental | Class 1 | Metal Burs Holder, BUR Retainer Case, BUR Holder, Plastic Holder | 2023 | 7 |
| Instrument, Filling, Plastic, Dental | Class 1 | Gauze Sponges Holder, Mixing Bowl, Spatula,, Suture Practice PAD, Dental Veneering Cleaning Box, Amalgam Carrier and 37 more | 2021 | 23 |
| Instrument, Hand, Calculus Removal | Class 1 | Dental Instrument | 2021 | 13 |
| Instruments, Dental Hand | Class 1 | dental instrument | 2021 | 64 |
| Light, Operating, Dental | Class 1 | led curing light, Dental Light | 2023 | 16 |
| Material, Impression Tray, Resin | Class 1 | metal impression tray, rotary impression tray | 2021 | 41 |
| Mirror, Mouth | Class 1 | autoclavable mouth mirror, mouth mirror with scale, dental mouth mirror, disposable mouth mirror | 2021 | 94 |
| Mouthpiece, Saliva Ejector | Class 1 | Dental Suction TIP, AIR Water Syringe TIP, Dental Saliva Ejector, surgical aspirator tip, suction tube, saliva ejector | 2023 | 68 |
| Needle, Dental | Class 1 | endo irrigation needle, micro prebent needle tip, Dental Needle, prebent needle tip, dental irrigation needle, dental needle tip with brush and 1 more | 2021 | 56 |
| Paper, Articulation | Class 1 | articulating paper | 2021 | 12 |
| Point, Paper, Endodontic | Class 1 | paper point, Absorbent Paper Points | 2021 | 35 |
| Point, Silver, Endodontic | Class 1 | Endo File | 2023 | 1 |
| Post, Root Canal | Class 1 | Fiber Post KIT, fiber post, Endo Post PIN | 2021 | 10 |
| Probe, Periodontic | Class 1 | Dental Examination KIT, Dental Instrument KIT, Disposable Probe, Dental Probe | 2021 | 34 |
| Retainer, Matrix | Class 1 | Ivory Matrix Bands, Matrix KIT, Dental Matrix Band, matrix sheets, Matrix band with retainer,, Dental Matrix Holder and 2 more | 2023 | 13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Eyewear | 2021 | 384 |
| Shield, Protective, Personnel | Class 1 | see clear eyewear, half face shield, Protective Light Hand Shield, eyewear, face shield | 2021 | 78 |
| Shoe And Shoe Cover, Conductive | Class 1 | Shoe Cover, bouffant cap | 2021 | 32 |
| Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | Endo File, Spreader File | 2021 | 17 |
| Strip, Polishing Agent | Class 1 | Dental Polishing Strip, Resin polishing strips, steel-STRIPROLL-RESIN, SS Polishing Strip | 2023 | 18 |
| Syringe, Cartridge | Class 2 | Luer Lock Syringe, dental irrigation syringe, Dental Syringes, Disposable Dental Syringes, 12cc utility syringe | 2023 | 3 |
| Tissue Culture, Accessories, Dental | Class 1 | Dental BIB Clip, Dental BIB, Dental BIB Holder, Dental Tissue Holder, Dental Tissue, Dental BIB With TIE-ON and 1 more | 2023 | 1 |
| Toothbrush, Manual | Class 1 | denture brush, toothbrush, orthodontic brush, Orthodontic KIT | 2021 | 244 |
| Tray, Fluoride, Disposable | Class 1 | Fluoride Foam Tray | 2023 | 22 |
| Tray, Impression, Preformed | Class 1 | Metal Impression Tray, impression tray, Plastic Impression Tray, Instrument Retainer Tray, Fluoride Foam Tray, stainless steel impression tray and 2 more | 2023 | 73 |
| Tray, Surgical | Class 1 | dental tray | 2021 | 36 |
| Tube Impression And Matrix | Class 1 | Matrix KIT | 2023 | 7 |
| Tube, Orthodontic | Class 1 | orthodontic tube, Buccal Tube | 2024 | 34 |
| Unit, Suction Operatory | Class 1 | dental unit, dental suction | 2021 | 23 |
| Unit, Syringe, Air And/Or Water | Class 1 | AIR Water Syringe Cover, AIR Water Syringe TIP, AIR Water Syringe | 2021 | 56 |
| Wax, Dental, Intraoral | Class 1 | Dental WAX, Orthodontic WAX | 2021 | 55 |
| Zinc Oxide Eugenol | Class 1 | Eugenol, Zinc Oxide Eugenol | 2021 | 6 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | dental cotton rolls, dental bibs, dental needles, suction tips, impression trays, sterilization pouches |
| Certifications | FDA, CE |
| Export markets | International |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.