Manufacturer registered with FDA
Foshan Cicada Dental Instrument Co, Ltd.
Foshan, China. Lists 11 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 15
- 510(k) clearances
- 42019–2022
- Markets registered in
- 749 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Foshan Cicada Dental Instrument 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 | Foshan Cicada Dental Instrument Co, Ltd. | 4 clearances | 2019–2022 | Below |
| European Union | EUDAMED | Manufacturer | Foshan Cicada Dental Instrument Co.,Ltd | 28 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FOSHAN CICADA DENTAL INSTRUMENT Co., Ltd. | 7 | 2022–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Foshan Cicada Dental Instrument Co.,LtdFOSHAN CICADA DENTAL INSTRUMENT CO.,LTD · Foshan CICADA Dental Instrument Co., LTD · +2 | 7 | 2018–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | FOSHAN CICADA DENTAL INSTRUMENT CO., LTD. | 5 | 2019–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Foshan Cicada Dental Instrument Co Ltd | 1 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FOSHAN CICADA DENTAL INSTRUMENT CO., LTD | 1 | 2026–2026 | 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 Foshan Cicada Dental 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 |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Disposable/Dental Irrigation Needle, Disposable/Dental Irrigation Syringe, | 2020 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Dental Electric Motor: NL 400-1,NL 400-2,NL 400-3, NL 400-4 | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Curing Light, Broad Spectrum Curing Light, CV-215 G1--G8, 215i, 215i Plus, 216, 218, DTO | 2021 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | CV/GX644, CV/GX652, CV/GX654, GK01L, GK02L, GK03L, GK45L, GN02L, GN45L, GN01, G401, G402, G445, G406, G408, G409, G410,G201, G245, G206, G208, G209, G210High Speed Handpiece: CV/GX602, CV/GX604, CV/GX612, CV/GX, CV/GX622, CV/GX624, CV/GX632, CV/GX634, CV/GX642Low Speed Handpiece:CV/DX, CV/DX802,J05/D05M/D05Z,J03W/D05M/D05Z, J04/D05M/D05Z, D02W/D02M/D02Z, Z45L/D02M/D02Z,Z01/D02M/D02,ZD04W/D04M/D04Z, D01W/D01M/D01Z, D05W/D04M/D04Z, D04W/D04M/D03Z, J03Z, D45L, D15L, DW15L, W201L, SG20, W20L | 2019 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Sonic Activator: Wave 2, SoniWave, SoniFlow | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Endo Irrigation Tips, Disposable Endo Irrigation Tips | 2020 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Automatic Crown Remover, Crown Remover | 2019 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha, Gutta Cutter | 2018 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Endo Files, Dental Engine Files, Endo Hand Files | 2025 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Endo Motor, Root Canal Motor Device T-Fine I, II, III, IV, V, VK-Endo I, II, III | 2021 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | Endo Files, Dental Engine Files, Endo Hand Files | 2016 |
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 Foshan Cicada Dental Instrument Co, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Mar 2022 | K202075 | Dental Electric Motor | EBW Handpiece and Cord Foot Controller |
| 12 Mar 2021 | K192649 | Endo Motor | EKX Ac-Powered Direct Drive Handpiece |
| 13 Feb 2020 | K192233 | LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 9 Dec 2019 | K181900 | Dental high speed handpiece, Dental low speed handpiece | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Foshan CICADA Dental Instrument Co., Ltd.FDA reg. 3009768364 | Foshan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051861). 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.