Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027320022

FEI Number

3027320022

Entity Name

Guangdong Xinuo Personal Care Products Co., Ltd

City/State/Country

Yunfu City Guangdong, CN

Establishment Address

4th Floor Building 1, NO.17 Xingguo Road, Xincheng Town, Xinxing County, Yunfu City Guangdong 527100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Xinuo Technology Co., Ltd (Owner Number: 10088958)

Owner / Operator Contact Address

B0276, Room 201, NO.226, Hedong Road, Liwan District, Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Saliva Ejector Mouth Mirror Thermoplastic Mouth Tray /Mouth Piece Sports Mouth Guard;Teeth Whitening Mouth Tray,Medical Face Shield Foam Strip Mouth Tray;Gel Prefilled Mouth Tray;Bruxism Mouth Guard Mouth Props, Endo Measure Block;Endo Clean Block Mixing Bowl,;Silicone Rubber Cup,;Plastic Dappen Dish; Mortar And Pestle, Medicine Bottle; Glass Dappen Dish Impression Tray Base, Impression Tray tongue cleaner Disposable Dental Instrument Kit Curved Utility Syringes,HP Mixing Tip;curved utility syringes Disposable air-water Syringe Tips,Cover Of air-water Syringe tips Brush Applicator anti-grinding braces Composite Dispenser Gun,;Impression Dispenser gun Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel; gingival barrier Disposable Dental Chair Cover Stop Snoring Solution;Anti Snore Kit;Stop Snoring Device; Anti Snore Mouth Piece;Snoring Stopper;Anti Snore Mouth Tray Dental Bib TOOTHBRUSH, MANUAL Dental Probe Cheek Retactor;mouth Opener;lip Retractor Oral Irrigator Forceps Snoring Vent/Stop Snoring tongue Stop Snoring Chin Strap;Anti Snore Jaw Supporter;Stop Snoring solution, Anti Snore Belt/Chin Strap Belt denture adhesive powder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2023-10-24
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2023-10-24
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-10-24
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2023-10-24
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-10-24
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2023-10-24
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2023-10-24
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2023-10-24
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2023-10-24
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2023-10-24
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2023-10-24
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-10-24
EIE	Dam, Rubber	Dental	Class 1	872.6300	2023-10-24
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2023-10-24
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2023-10-24
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-10-24
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-10-24
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2023-10-24
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-10-24
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-10-24
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2023-10-24
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2023-10-24
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Dental	Class 1	872.3490	2023-10-24

Official Correspondent

Frank Yang

US Agent Details

Wen Wang Business: Willow Glen Consultancy LLC Email: Wen.Wang@WillowGlenFDA.com Phone: (619) 8690249

Related Public Records

Same Entity

Guangzhou Xinuo Technology 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K884357	Precision Dynamics Corp.	PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM	1988-11-01

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3010741366	INTERSURGICAL S.P.A.	Mirandola (MO) Italy Modena, IT
3021023132	WUXI LYUSMILE IMP AND EXP CO.,LTD	WUXI Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027320022. Last updated year: 2026. Please use registration number 3027320022 when referencing this establishment in official correspondence.