Manufacturer registered with FDA
Shandong Zhushi Pharmaceutical Group Co., Ltd
Heze, China. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 47 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Shandong Zhushi Pharmaceutical Group 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 | Shandong Zhushi Pharmaceutical Group Co., Ltd | 15 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shandong Zhushi Pharmaceutical Group Co., Ltd | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shandong Zhushi Pharmaceutical Group Co Ltd | 2 | 2020–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shandong Zhushi Pharmaceutical Group | 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 Shandong Zhushi Pharmaceutical Group 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 | MOUTHPIECE, SALIVA EJECTOR | 2023 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental anesthesia needle | 2023 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Disposable Dental Instrument Kit | 2023 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | UNIT, SYRINGE, AIR ANDIOR WATER | 2023 |
| Roll CottonEFN · Class 1 | — | Maker | Absorbent Cotton Balls, Disinfection Cotton Ball, Swab and Piece, prophy angle, cotton roll/Dental cotton roll | 2021 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Cordless Oral Irigator/Cordless DentalFlosser, Teether, Nozzle Tips for Water FlosserOral irrigation unit/Dental Oral Irrigator, Water Flosser, DentalFlosser, Dental Water Jet, | 2023 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Mouthwash, Denture cleansing tablets, Cleanser, Denture, Denture Cleanser | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Thermoplastic Mouth Tray, Mouth Piece/Dental mouthpiece,Teeth whitening tray; TRAY, IMPRESSION, PREFORMED | 2023 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Dam;Dental Gum Dam;Gum Protector Gel ;Gingival Protection Gel | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Mouth Prop | 2023 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE, PERIODONTIC, Mouth Mirror | 2023 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Dental Probe | 2023 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | BIB/dental bib | 2023 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Dione Cold Light Tooth WhiteningInstrument, Enamel Care/Colour Corrector/Hyaluronic SerumTeeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL> ,Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials, | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Blunt tip dispensing needle, scanbody, analog | 2023 |
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 |
|---|---|---|
| SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTDFDA reg. 3013496867 | Heze Shandong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052646). 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.