Manufacturer registered with FDA
Guilin Kevin Peter Technology Co., Ltd.
Guilin, China. Lists 12 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 20
- 510(k) clearances
- 32026–2026
- Markets registered in
- 12189 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Guilin Kevin Peter Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Guilin Kevin Peter Technology Co., Ltd. | 3 clearances | 2026–2026 | Below |
| Colombia | INVIMA | Registration holder | GUILIN KEVIN PETER TECHNOLOGY CO., LTD. | 126 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Guilin Kevin Peter Technology Co., Ltd. | 14 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Guilin Kevin Peter Technology Co Ltd | 14 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GUILIN KEVIN PETER TECHNOLOGY CO., LTD. | 12 | 2025–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUILIN KEVIN PETER TECHNOLOGY CO., LTD. | 8 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Guilin Kevin Peter Technology Co Ltd | 5 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUILIN KEVIN PETER TECHNOLOGY CO., LTD | 3 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Guilin Kevin Peter Technology Co., LtdGuilin Kevin Peter Technology Co.,Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Guilin Kevin Peter Technology Co., Ltd. | 2 | 2024–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Guilin Kevin Peter Technology Co., Ltd. | 2 | 2023–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Guilin Kevin Peter Technology Co., Ltd. | 1 | 2025–2025 | 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 Kevin Peter Technology 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 |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Calcium Hydroxide Temporary Filling Material (KP-Cal )Injectable Root Canal Sealer (KP-Root SP) | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Flowable Restorative Material(KP-Flow LF, KP-Flow MF, KP-Flow HF) | 2026 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Flowable Restorative Material(KP-Flow LF, KP-Flow MF, KP-Flow HF) | 2026 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | 3D Printing Resin | 2024 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Light Cured Gingival BarrierRubber Dam | 2023 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Calcium Hydroxide Temporary Filling Material (KP-Cal ) | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Tooth Whitening Gel | 2023 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points and Bar | 2022 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | EDTA Root Canal Lubricating GelEDTA Solution | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Disposable Sterile Root Canal FileRoot Canal FileSterile Root Canal File | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | insta oneIntraoral ScannerSmile2, K-Scan, Smile ScanSwift Scan | 2023 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Intraoral Camera | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Guilin Kevin Peter Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Aug 2026 | K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | EBF Resin Tooth Shade Material |
| 25 Aug 2026 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | KIF Root Canal Filling Resin |
| 29 Jun 2026 | K261415 | Injectable Root Canal Sealer (KP-Root SP) | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUILIN KEVIN PETER TECHNOLOGY CO., LTD.FDA reg. 3023816720 | Guilin Guangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085586). 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.