Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023816720

FEI Number

3023816720

Entity Name

GUILIN KEVIN PETER TECHNOLOGY CO., LTD.

City/State/Country

Guilin Guangxi, CN

Establishment Address

North side of Linsu Rd, Lingui Town, Lingui Dist., Guilin, Guilin Guangxi 541100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guilin Kevin Peter Technology Co., Ltd. (Owner Number: 10085586)

Owner / Operator Contact Address

North side of Linsu Rd, Lingui Town, Lingui Dist., Guilin, CN-GX 541100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intraoral Scanner insta one Swift Scan Smile2, K-Scan, Smile Scan Intraoral Camera EDTA Root Canal Lubricating Gel EDTA Solution 3D Printing Resin Gutta Percha Points and Bar Light Cured Gingival Barrier Rubber Dam Surgical Loupes Tooth Whitening Gel Root Canal File iSee Tron X iSee 9000 iSee Next, iSee Next X Surgical Microscope DM Explore, DM Explore X iSee Pro, iSee Pro X iSee Tron Surgical Headlight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2023-02-07
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2023-09-04
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2023-09-04
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2024-11-14
EKM	Gutta-Percha	Dental	Class 1	872.3850	2022-07-06
EIE	Dam, Rubber	Dental	Class 1	872.6300	2023-07-14
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2025-11-21
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2023-09-04
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2023-06-19
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2022-08-06
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2026-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Guilin Kevin Peter 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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Similar Registrations

Registration Number	Establishment Name	Location
3045007778	CMEOS MEDICAL SCI & TECH (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3015786035	TUPEL LTD	Oxford Oxfordshire, GB
3035512103	SHENZHEN SHUHE TECHNOLOGY CO., LTD	Shenzhen Guangdong, CN
3044905014	FUSSEN IMAGING CO.,LTD.	Shenzhen Guangdong, CN
3010158379	DOF INC	Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023816720. Last updated year: 2026. Please use registration number 3023816720 when referencing this establishment in official correspondence.