Manufacturer registered with FDA
ZOGEAR Medical Co., Ltd.
Yizheng, China. Lists 45 dental device types with FDA across 1 registered establishment.
- Device types listed
- 45
- Brands and models
- 47
- 510(k) clearances
- 0as applicant
- Markets registered in
- 829 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name ZOGEAR Medical 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 | ZOGEAR Medical Co., Ltd. | 45 device types | — | Below |
| Australia | TGA | Manufacturer | ZOGEAR Medical Co Ltd | 9 | 2023–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ZOGEAR MEDICAL Co., Ltd. | 5 | 2024–2026 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | ZOGEAR Medical Co., Ltd. | 5 | 2025–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ZOGEAR Medical Co., Ltd. | 4 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZOGEAR MEDICAL CO., LTD | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ZOGEAR Medical Co., Ltd.ZOGEAR Medical Co.,Ltd. | 2 | 2022–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Zogear Medical Co, Ltd. | 2 | 2021–2023 | 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 ZOGEAR Medical 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 | 2013 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | CanlPro TipsNEEDLE, DENTAL | 2013 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | INSTRUMENTS, DENTAL HAND | 2013 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2013 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | MATERIAL, IMPRESSION TRAY, RESIN | 2013 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | UNIT, SUCTION OPERATORY | 2013 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | UNIT, SYRINGE, AIR AND/OR WATER | 2013 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | BAND, ELASTIC, ORTHODONTIC | 2013 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | BAND, PREFORMED, ORTHODONTIC | 2016 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC | 2013 |
| Articulation PaperEFH · Class 1 | — | Maker | PAPER, ARTICULATION | 2013 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | FORCEPS, ARTICULATION PAPER | 2013 |
| Roll CottonEFN · Class 1 | — | Maker | COTTON, ROLL | 2013 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Electric Dental Water Flosser | 2026 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Cleaning Tablet | 2025 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TOOTHBRUSH, MANUAL | 2013 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | WAX, DENTAL, INTRAORAL | 2013 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Holder, film, x-ray | 2013 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | CUP, PROPHYLAXIS | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TRAY, IMPRESSION, PREFORMED | 2013 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | CanalPro color syringesSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | 2013 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 2013 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | ACCESSORIES, RETRACTOR, DENTAL | 2013 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | PROBE, PERIODONTIC | 2013 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | 2013 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | HANDLE, INSTRUMENT, DENTAL | 2013 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | FRAME, RUBBER DAM | 2013 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | POLISHING AGENT | 2016 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE | 2013 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | CARRIER, AMALGAM, OPERATIVE | 2013 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | 2013 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | POINT, PAPER, ENDODONTIC | 2013 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | 2016 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | FILE, PULP CANAL, ENDODONTIC | 2013 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | INSTRUMENT, HAND, CALCULUS REMOVAL | 2013 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT | 2013 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | POST, ROOT CANAL | 2013 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | ZINC OXIDE EUGENOL | 2013 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | FLOSS, DENTAL | 2013 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental Bib | 2021 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Dental Disposable Fluoride Tray | 2025 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue scraper | 2025 |
| Over the Counter Wax Impregnated Cotton Denture Pad CushionNKJ · Class 1 | — | Maker | CUSHION, PAD, DENTURE, WAX IMPREGNATED COTTON, OVER THE COUNTER | 2013 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT | 2015 |
| Prescription Denture CleanserNUX · Class 1 | — | Maker | Cleanser, denture, prescription | 2013 |
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 |
|---|---|---|
| ZOGEAR Medical Co., Ltd.FDA reg. 3010583458 | Yizheng Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045283). 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.