Manufacturer registered with FDA
Jiangsu Yabaobao Medical Instrument Co.,Ltd.
Zhenjiang, China. Lists 34 dental device types with FDA across 1 registered establishment.
- Device types listed
- 34
- Brands and models
- 34
- 510(k) clearances
- 0as applicant
- Markets registered in
- 440 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Jiangsu Yabaobao Medical 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 | Jiangsu Yabaobao Medical Instrument Co.,Ltd. | 34 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Jiangsu Yabaobao Medical Instrument Co.,Ltd. | 28 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | JIANGSU YABAOBAO MEDICAL INSTRUMENT CO.,LTD.Jiangsu Yabaobao Medical Instrument Co.,Ltd. · Jiangsu Yabaobao Medical Instrument Co.Ltd. | 9 | 2020–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Jiangsu Yabaobao Medical Instrument Co.,Ltd. | 3 | 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 Jiangsu Yabaobao Medical 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | — | 2011 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dispensing tipPre-bent needle tip | 2011 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Amalgam Dental CapsuleDZS · Class 1 | — | Maker | — | 2013 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Disposable dental mirror | 2011 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic arch wire,Orthodontic band,Orthodontic buccal tubePolishing brush,Elastance chain,Ligature tie,Orthodontic Bracket,tooth model,Orthodontic kitSeparator elastormeric,probe (forceps),Orthodontic elastic | 2011 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Chewies | 2022 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Disposable dental kit, Disposable dental tweezer | 2011 |
| Roll CottonEFN · Class 1 | — | Maker | COTTON BALL | 2011 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Brush applicatorBrush applicator with handleDental BrushMicro applicator | 2011 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | WAX,DENTAL,INTRAORAL | 2019 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | — | 2018 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Film positioning system complete | 2022 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Dappen dish,glass,plastic Glass mortar & pestle Alcohol lamp No-stick mixing cup | 2011 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Bite trayDental TrayPlastic Tray | 2011 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Air-water syringe tip (metal & plastic), Surgical tip Air-water syringe, tip cover, High volume evacuator | 2011 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Disposable dental syringe | 2011 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | COMPOSITE GUNMIXING TIP | 2012 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek retractor | 2011 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Disposable dental probe | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | ORTHODONTIC KIT | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 2013 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | — | 2017 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Tofflemire matrix bands | 2022 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | GUTTA-PERCHA POINT,ABSORBENT PAPER POINTS | 2015 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | ENDODONTIC FILE | 2015 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | ENDODONTIC PULP CANAL FILE | 2015 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | — | 2011 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | — | 2011 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | — | 2011 |
| Carboxymethylcellulose Sodium (40-100&) Denture AdhesiveKOQ · Class 1 | — | Lister | — | 2018 |
| Resin ApplicatorKXR · Class 1 | — | Maker | MICRO BRUSH APPLICATOR | 2013 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Disposable cupsUniversal barrier filmUniversal barrier film dispenser | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Jiangsu Yabaobao Medical Instrument Co.,Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Premium Plus International Limited (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Dec 2010 | K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Jiangsu Yabaobao Medical Instrument Co.,Ltd.FDA reg. 3008887731 | Zhenjiang Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035953). 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.