Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015168527

FEI Number

3015168527

Entity Name

Shenzhen Senlede Technologies Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

203, Building 5, Hanhaida(Tianliao) Science and Technology Park, Seventh Industrial Zone, Tianliao Community, Yutang Street, Guangming District, Shenzhen Guangdong 518132, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Senlede Technologies Co., Ltd (Owner Number: 10059571)

Owner / Operator Contact Address

203, Building 5, Hanhaida(Tianliao) Science and Technology Park, Seventh Industrial Zone, Tianliao Community, Yutang Street, Guangming District, Shenzhen, CN-GD 518132, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stop Snoring Solution;Anti Snore Kit;Stop Snoring Device; Anti Snore Mouth Piece Snoring Stopper;Anti Snore Mouth Tray Forceps Stop Snoring Chin Strap;Anti Snore Jaw Supporter Stop Snoring solution, Anti Snore Belt/Chin Strap Belt;Snoring Vent/Stop Snoring tongue Gel Prefilled Mouth Tray;Bruxism Mouth Guard; Thermoplastic Mouth Tray /Mouth Piece Sports Mouth Guard;Teeth Whitening Mouth Tray,Medical Face Shield; Foam Strip Mouth Tray Teeth Whitener Teeth Whitening Gel 3ml /5ml/10ml; Professional Whitening Gel: Remineralization Gel/ Desensitizing Gel Teeth Bleaching Kit /teeth whitening foam; Teeth Whitening Mouth Tray Led Light Teeth Whitening Mouth Tray Light; Teeth Whitening Strips:Coconut Oil Pulling: Coconut Oil Sachet ProLite Teeth Whitening Device; Natural+ LED teeth whitening lamp; Teeth Whitening System; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syringe Gel Teeth Whitening Kit/teeth Whitening Home Kit; Double Elastic Gel Strips/Dry Strips/Teeth Bleaching System/ Dissolving Strip: Teeth Whitening Powder; Charcoal Teeth Whitening Powder; Double Barrel Syringe Gel; ;ProLite Teeth Whitening Device; Teeth Whitening Pen/Empty Pen/Bleaching Pen Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel; gingival barrier denture adhesive powder Sonic Led Toothbrush; toothbrush;bamboo toothbrush; optical whitening toothbrush Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush Disposable Dental Instrument Kit Cheek Retactor;mouth Opener;lip Retractor Universal Barrier Film;Denture Box Dental Bib Bur Holder/Box;Dispenser;Cotton Roll Dispenser; Dental Instrument Tray;Holder Of Medicine Bottle Dental Bib Holder, Denture Transportation Box; Endo Holder Composite Dispenser Gun,;Impression Dispenser gun Mouth Props, Endo Measure Block;Endo Clean Block Oral Irrigator Brush Applicator Denture Cleansing Tablet curved utility syringes Disposable air-water Syringe Tips,Cover Of air-water Syringe tips; Curved Utility Syringes,HP Mixing Tip Mouth Mirror Dental Probe Spatular anti-grinding braces Teeth Wipes;Brush Ups; Finger Brush; Oral Brush Ups

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-02-08
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2019-02-08
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2019-02-01
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-02-01
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2019-02-08
EIE	Dam, Rubber	Dental	Class 1	872.6300	2019-02-08
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Dental	Class 1	872.3490	2021-10-14
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2019-02-08
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2019-02-08
EIG	Retractor, All Types	Dental	Class 1	872.4565	2019-02-01
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2019-02-08
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-02-08
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-02-08
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-02-08
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2019-02-08
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2020-12-01
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2019-02-08
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2019-02-08
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2019-02-08
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2019-02-08
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2019-02-08
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2019-02-08
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2021-10-14
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2019-02-08

Official Correspondent

Jefferson Le

US Agent Details

Noah Zhang Business: HYPERCERT LIMITED Email: hycerfda@hycerglobal.com Phone: (863) 3233636

Related Public Records

Same Entity

Shenzhen Senlede Technologies 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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K884357	Precision Dynamics Corp.	PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM	1988-11-01
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015168527. Last updated year: 2026. Please use registration number 3015168527 when referencing this establishment in official correspondence.