Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008763803

FEI Number

3008763803

Entity Name

XIAMEN YIZHOU IMP. & EXP. CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

201,2F,Huili Industrial Park,Meixi Rd.,Tong An District,, Xiamen Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Xiamen Yizhou Imp. & Exp. Co., Ltd. (Owner Number: 10053196)

Owner / Operator Contact Address

201,2F,Huili Industrial Park,Meixi Rd.,Tong An District,, Xiamen, CN-FJ 361100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Impression Mouth Tray(For grinding,TeethWhitening) Anti Snore Mouth Tray Mouthguard plastic case SilentZPro 2 Cheek Retractor Tranquility Pro 2 Tranquility PRO Anti-Snoring Mouth Guard Serenity Pro 2 Eliminator Pro 2 Somnos Anti-Snoring Mouth Guard Somnos Pro 2 Tranquility Tranquility PRO Tranquility Anti-Snoring Mouth Guard Intelliguard Pro Tranquility PRO 2 Anti-Snoring Mouth Guard Bright Guard Pro 2 Nasal Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2016-11-08
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-05-10
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-12-30
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2022-12-20
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-11-08
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2021-01-08
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-01-08
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2016-11-08

Official Correspondent

Elaine Huang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Xiamen Yizhou Imp. & 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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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

Registration Number	Establishment Name	Location
3013443455	VAMCO, LLC	Albuquerque, NM, US
3030268763	OWL DENTAL	San Leandro, CA, US
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3014268398	LLRN PERSONAL CARE (SHENZHEN) CO.,LTD	shenzhen Guangdong, CN
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008763803. Last updated year: 2026. Please use registration number 3008763803 when referencing this establishment in official correspondence.