Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011215096

FEI Number

3011215096

Entity Name

GUILIN YIKESHI Medical Device CO LTD

City/State/Country

Guilin Guangxi, CN

Establishment Address

D-8, Guilin National High-tech Zone Information Industrial Park, Chaoyang Road, Qixing District, Guilin Guangxi 541004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guilin Yikeshi Medical Instrument Co Ltd (Owner Number: 10047368)

Owner / Operator Contact Address

D-8, Guilin National High-tech Zone Information Industrial Park, Chaoyang Road, Qixing District, Guilin, CN-GX 541004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Absorbent Paper Points Loupe, Diagnostic, Surgical Magnifying Glasses Medical Trolley Cordless Headlight xp-33R xp-P1 xp-GD4 xp-NK7 xp-GS5 xp-GD2 xp-33L xp-PD2L xp-GK1 xp-GS4 xp-PM2L xp-PS2-V xp-GD1 xp-SU4 xp-PD1 xp-37L xp-PTU xp-PS2R xp-GN5 xp-PM2R xp-GN3 xp-37 xp-GS3 xp-31 xp-GK7 xp-GC2 xp-PM1 xp-G4 xp-SU6 xp-PS2L xp-37R xp-PS6-V xp-33 xp-GS2 xp-P2R xp-G2 xp-G5 xp-PS1 xp-G1 xp-GS1 xp-GM1 xp-NK6 xp-NK1 xp-G3 xp-GN2 xp-PD2R xp-GN4 xp-39 xp-GD3 xp-GK6 xp-GC1 xp-P2L xp-GD5 xp-UI2 xp-IM1-V xp-IP2-3 xp-OT4-V xp-UI7 xp-IP3-4 xp-IM3A xp-IM1 xp-IM4P xp-IM2P Scaler Handpiece, Sandblaster Handpiece, Wench xp-UI8 xp-UI1 xp-IM2A xp-IM1S-V xp-IM3P xp-IM4A xp-IM1SP-V xp-UI9 Dental Implant Plate xp-E10D xp-E5D xp-P3 xp-PS3 xp-ED11 xp-PM3 xp-NK6 xp-EM11D xp-EM4D xp-PM3D xp-NK6D xp-ED10D xp-ES11D xp-E11 xp-ES11 xp-E4D xp-ED4D xp-PD3D xp-ED5D xp-EM5 xp-ED5 xp-E11D xp-ES10D xp-ES5 xp-ES4 xp-ES5D xp-EM4 xp-GE20D xp-PS3D xp-PD3 xp-GC2 xp-EM10D xp-EM11 xp-GK6D xp-PC1 xp-GK6 xp-P3D xp-ED4 xp-E5 xp-39 xp-ED11D xp-E4 xp-37 xp-EM5D xp-ES4D DENTURE BOX xp-BT5 xp-BS2R-V 2 xp-BT3 xp-OT8L-V xp-Pirahna xp-BS1-V xp-BS2R-V xp-BS5-V 2 xp-US2 xp-OT4-V xp-BS6F-V xp-IM3P-V xp-BT4 xp-BS2L-V xp-US3 xp-BS4-V-2 xp-US6 xp-LT1 xp-IP2-3 V xp-BS6-V 2 xp-IP2-3 xp-US1 xp-OT8R-V xp-US5 xp-BS6F-V 2 xp-OT7S-3V xp-IP3-4 V xp-IM4P-V xp-BS5-V xp-US4 xp-BS2L-V 2 xp-IM4A-V xp-BS1-V 2 xp-BS4-V xp-OT7S-4V xp-Piranha 2 xp-BS6-V xp-BT1 xp-HC-5 xp-HC-1 xp-HC-4 xp-HC-8 xp-HC-3 xp-HC-7 xp-HC-6 xp-HC-2 Salivary Tube xp-LC1-V xp-E11 xp-UE1 xp-UE4 xp-EX1 xp-OP7-V xp-SAD xp-ED11 xp-ES11 xp-LC1-V 2 xp-LC190-V 2 xp-EX2 xp-SMRD xp-SPL xp-ES11D xp-S70 xp-EM11 xp-LC2R-V xp-ED11D xp-PD2RD xp-PD2R xp-LC2-V xp-EX3 xp-UE3 xp-EM11D xp-PD2LD xp-SPR xp-SA xp-SPRD xp-UE2 xp-SPLD xp-LC190-V xp-LC2R-V 2 xp-LC2L-V xp-LC2-V 2 xp-SML xp-S90 xp-PD2L xp-SMLD xp-S90D xp-S70D xp-E11D xp-LC2L-V 2 xp-LC2L-V xp-SL1-V 2 xp-ST1 xp-ST4 xp-SL4-V xp-SL2-V 2 xp-SL1-V xp-UL3 xp-SL3-V xp-SL3-V 2 xp-SL5-V 2 xp-SL5-V xp-UL2 xp-LC2R-V xp-UL5 xp-UL4 xp-ST5 xp-ST2 xp-SL2-V xp-UL1 xp-SL4-V 2 xp-ST3 xp-PRT xp-SBMR xp-SBDL xp-SBS2 xp-SBM3 xp-SBNL xp-CP-1 xp-SB2 xp-CP-2 xp-SBSR xp-SB3 xp-SBS3 xp-SBD3 xp-SBM2 xp-CP-3 xp-CP-R xp-SBNR xp-SBR xp-CP-P xp-ED1 xp-SBN3 xp-CP-L xp-SB1 xp-SBD1 xp-SBN2 xp-EK8 xp-EM1 xp-SBML xp-NK8 xp-SBSL xp-SBS1 xp-SBD2 xp-E1 xp-SBM1 xp-SBL xp-SBDR xp-SBN1 xp-ES1 xp-35A XP-35C xp-35B Operating Microscope Plaque Indicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2025-01-23
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2025-01-23
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2025-01-23
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2025-01-23
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2014-08-21
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2014-08-21
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2025-01-23
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2014-08-21
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2025-01-23
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2014-08-21
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2014-08-21
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2025-01-23
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2014-08-21
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2014-08-21
EIS	Remover, Crown	Dental	Class 1	872.4565	2014-08-21
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2014-08-18
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2014-08-21
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2025-01-23
NYH	Plaque Disclosing Kit	Dental	Class 2	872.1740	2025-01-23

Official Correspondent

Ai Juan Yang

US Agent Details

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

Related Public Records

Same Entity

Guilin Yikeshi Medical Instrument 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011215096. Last updated year: 2026. Please use registration number 3011215096 when referencing this establishment in official correspondence.