Manufacturer registered with FDA
Shenzhen Senlede Technologies Co., Ltd
Shenzhen, China. Lists 22 dental device types with FDA across 1 registered establishment.
- Device types listed
- 22
- Brands and models
- 32
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Senlede Technologies 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 | Shenzhen Senlede Technologies Co., Ltd | 22 device types | — | Below |
| Israel | AMAR | Manufacturer | Shenzhen Senlede Technologies Co., Ltd | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shenzhen Senlede Technologies Co., Ltd | 1 | 2021–2021 | 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 Shenzhen Senlede Technologies 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 | Mouth Props, Endo Measure Block;Endo Clean Block | 2019 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Spatular | 2019 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Disposable Dental Instrument Kit | 2019 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Saliva Ejector | 2019 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Oral Irrigator | 2020 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture Cleansing Tablet | 2019 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Teeth Wipes;Brush Ups; Finger Brush; Oral Brush Ups | 2019 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Forceps | 2019 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Gel Prefilled Mouth Tray;Bruxism Mouth Guard; Thermoplastic Mouth Tray /Mouth PieceSports Mouth Guard;Teeth Whitening Mouth Tray,Medical Face Shield; Foam Strip Mouth Tray | 2019 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel; gingival barrier | 2019 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | curved utility syringesDisposable air-water Syringe Tips,Cover Of air-water Syringe tips; Curved Utility Syringes,HP Mixing Tip | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retactor;mouth Opener;lip Retractor | 2019 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Mouth Mirror | 2019 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Dental Probe | 2019 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush, Sonic Toothbrush, Electric Led ToothbrushSonic Led Toothbrush; toothbrush;bamboo toothbrush; optical whitening toothbrush | 2019 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2019 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental Bib | 2019 |
| Carboxymethylcellulose Sodium or Polyvinyl Methylether Maleic Acid Calcium-SodiumKOT · Class 1 | Denture cleansers & adhesives | Maker | denture adhesive powder | 2021 |
| Tongue ScraperLCN · Class 1 | — | Maker | anti-grinding braces | 2021 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Dissolving Strip: Teeth Whitening Powder; Charcoal Teeth Whitening Powder; Double Barrel Syringe Gel;ProLite Teeth Whitening Device; Natural+ LED teeth whitening lamp;Teeth Bleaching Kit /teeth whitening foam; Teeth Whitening Mouth Tray Led LightTeeth Whitener Teeth Whitening Gel 3ml /5ml/10ml; Professional Whitening Gel: Remineralization Gel/ Desensitizing GelTeeth Whitening Kit/teeth Whitening Home Kit; Double Elastic Gel Strips/Dry Strips/Teeth Bleaching System/Teeth Whitening Mouth Tray Light; Teeth Whitening Strips:Coconut Oil Pulling: Coconut Oil SachetTeeth Whitening System; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syringe Gel;ProLite Teeth Whitening Device; Teeth Whitening Pen/Empty Pen/Bleaching Pen | 2019 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | tongue cleaner | 2021 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Protect Glasses | 2019 |
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 |
|---|---|---|
| Shenzhen Senlede Technologies Co., LtdFDA reg. 3015168527 | Shenzhen Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059571). 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.