Manufacturer registered with FDA
Guilin Yikeshi Medical Instrument Co Ltd
Guilin, China. Lists 20 dental device types with FDA across 1 registered establishment.
- Device types listed
- 20
- Brands and models
- 295
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1037 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name Guilin Yikeshi Medical Instrument Co Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Guilin Yikeshi Medical Instrument Co Ltd | 20 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Guilin Yikeshi Medical Instrument Co., Ltd | 12 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GUILIN YIKESHI MEDICAL INSTRUMENT CO, LTD | 8 | 2016–2016 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Guilin Yikeshi Medical Instrument CO.,LTD | 6 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Guilin Yikeshi Medical Instrument Co Ltd | 4 | 2022–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUILIN YIKESHI MEDICAL INSTRUMENT CO., LTD. | 2 | 2022–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Guilin Yikeshi Medical Instrument Co., Ltd.Guilin Yikeshi Medical Instrument Co.,Ltd. | 2 | 2020–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUILIN YIKESHI MEDICAL INSTRUMENT CO.,LTD. | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Guilin Yikeshi Medical Instrument co ltd | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Guilin Yikeshi Medical Instrument Co., Ltd. | 1 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Guilin Yikeshi Medical Instrument Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Salivary Tube | 2025 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | SONIC IRRIGATOR TIP, IRRIGATION NEEDLE TIPS | 2025 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Dental Cleaning | 2025 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | xp-PRT | 2014 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental Reflector | 2025 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | xp-CP-1xp-CP-2xp-CP-3xp-CP-Lxp-CP-Pxp-CP-Rxp-E1xp-ED1xp-EK8xp-EM1 27 morexp-ES1xp-NK8xp-SB1xp-SB2xp-SB3xp-SBD1xp-SBD2xp-SBD3xp-SBDLxp-SBDRxp-SBLxp-SBM1xp-SBM2xp-SBM3xp-SBMLxp-SBMRxp-SBN1xp-SBN2xp-SBN3xp-SBNLxp-SBNRxp-SBRxp-SBS1xp-SBS2xp-SBS3xp-SBSLxp-SBSR | 2014 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | xp-35Axp-35BXP-35C | 2014 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points | 2025 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2025 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | xp-37xp-39xp-E10Dxp-E11xp-E11Dxp-E4xp-E4Dxp-E5xp-E5Dxp-ED10D 35 morexp-ED11xp-ED11Dxp-ED4xp-ED4Dxp-ED5xp-ED5Dxp-EM10Dxp-EM11xp-EM11Dxp-EM4xp-EM4Dxp-EM5xp-EM5Dxp-ES10Dxp-ES11xp-ES11Dxp-ES4xp-ES4Dxp-ES5xp-ES5Dxp-GC2xp-GE20Dxp-GK6xp-GK6Dxp-NK6xp-NK6Dxp-P3xp-P3Dxp-PC1xp-PD3xp-PD3Dxp-PM3xp-PM3Dxp-PS3xp-PS3D | 2014 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Obturation Systemxp-34xp-34sxp-35xp-35Axp-35Bxp-35Cxp-39xp-G7xp-GC2 7 morexp-GD7xp-GK7xp-GM7xp-GN7xp-GS7xp-NK7xp-PRT | 2014 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | xp-LC2L-Vxp-LC2R-Vxp-SL1-Vxp-SL1-V 2xp-SL2-Vxp-SL2-V 2xp-SL3-Vxp-SL3-V 2xp-SL4-Vxp-SL4-V 2 12 morexp-SL5-Vxp-SL5-V 2xp-ST1xp-ST2xp-ST3xp-ST4xp-ST5xp-UL1xp-UL2xp-UL3xp-UL4xp-UL5 | 2014 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | xp-E11xp-E11Dxp-ED11xp-ED11Dxp-EM11xp-EM11Dxp-ES11xp-ES11Dxp-EX1xp-EX2 33 morexp-EX3xp-LC1-Vxp-LC1-V 2xp-LC190-Vxp-LC190-V 2xp-LC2-Vxp-LC2-V 2xp-LC2L-Vxp-LC2L-V 2xp-LC2R-Vxp-LC2R-V 2xp-OP7-Vxp-PD2Lxp-PD2LDxp-PD2Rxp-PD2RDxp-S70xp-S70Dxp-S90xp-S90Dxp-SAxp-SADxp-SMLxp-SMLDxp-SMRDxp-SPLxp-SPLDxp-SPRxp-SPRDxp-UE1xp-UE2xp-UE3xp-UE4 | 2014 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | xp-BS1-Vxp-BS1-V 2xp-BS2L-Vxp-BS2L-V 2xp-BS2R-Vxp-BS2R-V 2xp-BS4-Vxp-BS4-V-2xp-BS5-Vxp-BS5-V 2 28 morexp-BS6-Vxp-BS6-V 2xp-BS6F-Vxp-BS6F-V 2xp-BT1xp-BT3xp-BT4xp-BT5xp-IM3P-Vxp-IM4A-Vxp-IM4P-Vxp-IP2-3xp-IP2-3 Vxp-IP3-4 Vxp-LT1xp-OT4-Vxp-OT7S-3Vxp-OT7S-4Vxp-OT8L-Vxp-OT8R-Vxp-Pirahnaxp-Piranha 2xp-US1xp-US2xp-US3xp-US4xp-US5xp-US6 | 2014 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | xp-31xp-33xp-33Lxp-33Rxp-37xp-37Lxp-37Rxp-39xp-G1xp-G2 43 morexp-G3xp-G4xp-G5xp-GC1xp-GC2xp-GD1xp-GD2xp-GD3xp-GD4xp-GD5xp-GK1xp-GK6xp-GK7xp-GM1xp-GN2xp-GN3xp-GN4xp-GN5xp-GS1xp-GS2xp-GS3xp-GS4xp-GS5xp-NK1xp-NK6xp-NK7xp-P1xp-P2Lxp-P2Rxp-PD1xp-PD2Lxp-PD2Rxp-PM1xp-PM2Lxp-PM2Rxp-PS1xp-PS2-Vxp-PS2Lxp-PS2Rxp-PS6-Vxp-PTUxp-SU4xp-SU6 | 2014 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | xp-HC-1xp-HC-2xp-HC-3xp-HC-4xp-HC-5xp-HC-6xp-HC-7xp-HC-8 | 2014 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Scaler Handpiece, Sandblaster Handpiece, Wenchxp-IM1xp-IM1-Vxp-IM1S-Vxp-IM1SP-Vxp-IM2Axp-IM2Pxp-IM3Axp-IM3Pxp-IM4A 9 morexp-IM4Pxp-IP2-3xp-IP3-4xp-OT4-Vxp-UI1xp-UI2xp-UI7xp-UI8xp-UI9 | 2014 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | DENTURE BOX | 2025 |
| Plaque Disclosing KitNYH · Class 2 | — | Maker | Plaque Indicator | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUILIN YIKESHI Medical Device CO LTDFDA reg. 3011215096 | Guilin Guangxi, China | Manufacturer |
Other names on FDA records
GUILIN YIKESHI Medical Device CO LTD
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047368). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.