Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021023132

FEI Number

3021023132

Entity Name

WUXI LYUSMILE IMP AND EXP CO.,LTD

City/State/Country

WUXI Jiangsu, CN

Establishment Address

Suite 2509, No.990,Western Jianghai Rd., Wuxi,214073,Jiangsu Province ,China, WUXI Jiangsu 214073, CN

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

WUXI LYUSMILE IMP AND EXP CO.,LTD (Owner Number: 10082225)

Owner / Operator Contact Address

Suite 2509,Building Zhihui 568,No.990,Western Jianghai Road, Wuxi,214073,Jiangsu Province ,China, WUXI, CN-JS 214073, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

articulating paper DENTAL INSTRUMENT IMPLANT PROTECTION KIT DENTAL IMPLANT KIT DENTAL IMPLNAT IRRIGATION KIT DENTAL GAUZE ORTHODONTIC WAX DENTAL WAX AIR WATER SYRINGE AIR WATER SYRINGE TIP AIR WATER SYRINGE COVER SPREADER FILE ENDO FILE saliva ejector x-ray Lead Apron dental sleeve Lead Apron ENDO GAUGE ORTHODONTIC GAUGE ENDO FILE RULER DENTAL GAUGE FLUORIDE FOAM TRAY EYEWEAR led curing light DENTAL LIGHT orthodontic bracket DENTAL ALIGNER invisable bracket metal impression tray rotary impression tray WAX GAUGE Techincian Tools Series Dental Pencil Kit DENTAL STONE SAW Casting Investment Ring Disposable Plastic Model electric wax knife micro motor dental vibrator WAX POT Alginate impression dental stone mixer Brass Dowel Pin Gas light Alginate impression MIXER plastic sheet vacumm former Twin pins crucible ENDO FILE DENTAL ISOLATION GOWN dental lab gown SURGICAL GOWN Zin Articulator Disposable Articulator BRASS ARTICULATOR PLASTIC ARTICULATOR FIBER POST DRILL INTRAL ORAL TIP DENTAL DRILL bouffant cap SHOE COVER Absorbent Paper Points paper point PLASTIC IMPRESSION TRAY stainless steel impression tray METAL IMPRESSION TRAY impression tray Impression Bite Begistration Tray ABS IMPRESSION TRAY FLUORIDE FOAM TRAY INSTRUMENT RETAINER TRAY disposable mouth mirror dental mouth mirror mouth mirror with scale autoclavable mouth mirror COTTON APPLICATOR Composite Brush Valustick Sticky Applicators MICRO BRUSH Colorful brush applicator Micro Applicator Bendable Brush Applicator DENTAL PROBE DENTAL INSTRUMENT KIT DENTAL EXAMINATION KIT DISPOSABLE PROBE NON WOVEN SPONGE COTTON ROLLS dental gauze DENTAL COTTON ROLLS DENTAL ALLOY Protective Light Hand Shield face shield half face shield see clear eyewear eyewear Digital sensor Positioner X-ray Film Bag position arm digital sensor holder Film Positioning System Complete Imaging Plate Barrier Envelopers X-RAY Positioner Simple X-Ray Film Holder position ring X-ray Film Washer Clip X-ray Film Holder X-ray Film Mounts-Clip On BUR HOLDER PLASTIC HOLDER BUR RETAINER CASE METAL BURS HOLDER DENTAL EVACUATOR TIP DENTAL EVACUATOR tongue protector rubber dam cheek retractor RUBBER MOUTH SUPPORT CHEEK RETRACTOR denture brush denture cleaner MATRIX KIT BARRIER ENVELOPE IP BAG dental Speparator Power Chain ligature tie dental elastic. Natural Elastic LIGATURE TIE GUN ORTHODONTIC CLAMP ARTICULATING ARM RUBBER DAM CLAMP RUBBER MOUTH SUPPORT rubber dam kit dental rubber dam frame PLASTIC RUBBER DAM FRAME Matrix band with retainer, DENTAL MATRIX HOLDER matrix sheets MATRIX KIT DENTAL MATRIX RETAINER Plastic matrix bands Ivory Matrix Bands DENTAL MATRIX BAND dental instrument SURGICAL BLADE DENTAL BLADE dental irrigation syringe Disposable Dental Syringes 12cc utility syringe Dental Syringes Luer Lock Syringe toothbrush orthodontic brush ORTHODONTIC KIT denture brush dental rubber dam RUBBER DAM rubber dam forceps RUBBER DAM KIT fiber post ENDO POST PIN FIBER POST KIT orthodontic tube BUCCAL TUBE dental disc dental white stone dental polisher dental carbide cutter dental diamond burs dental diamond disc dental carbide bur dental unit dental suction DENTAL ORTHODONTIC BRACKET dental wax

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFH	Paper, Articulation	Dental	Class 1	872.6140	2021-10-20
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2021-10-21
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-02-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-10-21
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2021-10-21
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2021-10-21
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2021-10-21
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2021-06-28
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2021-10-21
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2023-02-07
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2023-02-07
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2021-10-21
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2023-02-07
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2021-10-20
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2021-10-21
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-10-21
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2021-10-21
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-10-21
EJP	Articulators	Dental	Class 1	872.3150	2023-02-07
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2023-02-07
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2021-10-21
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2021-10-21
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-02-07
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2021-06-28
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-10-21
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2021-10-21
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-10-21
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2023-02-07
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2021-10-21
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2021-10-21
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2023-02-07
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2023-02-07
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2021-06-28
NUX	Cleanser, Denture, Prescription	Dental	Class 1	872.3520	2021-10-21
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2023-02-07
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2021-10-21
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2021-10-21
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2023-02-07
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2023-02-07
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2023-02-07
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-10-21
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2021-10-21
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2023-02-07
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-10-21
EIE	Dam, Rubber	Dental	Class 1	872.6300	2023-02-07
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2023-02-07
ELR	Post, Root Canal	Dental	Class 1	872.3810	2021-10-21
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2024-01-22
EJL	Bur, Dental	Dental	Class 1	872.3240	2023-02-07
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2021-10-21
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2023-02-07
NKJ	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Dental	Class 1	872.3540	2021-10-21

Official Correspondent

JING LYU

US Agent Details

Eli Dardashty Email: eli@ddssupply.com Phone: (323) 5598683

Related Public Records

Same Entity

WUXI LYUSMILE IMP AND EXP CO.,LTD

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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

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3023339277	ANHUI JM HEALTHCARE PRODUCTS CO.,LTD.	Shouxian Anhui, CN
8010414	PRODUITS DENTAIRES SA	VEVEY (SUISSE) Vaud, CH
3014683120	JMU DENTAL, INC	Fullerton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021023132. Last updated year: 2026. Please use registration number 3021023132 when referencing this establishment in official correspondence.