Manufacturer registered with FDA
Debo Medical Technology (Shijiazhuang) Co., Ltd.
Shijiazhuang, China. Lists 63 dental device types with FDA across 1 registered establishment.
- Device types listed
- 63
- Brands and models
- 182
- 510(k) clearances
- 0as applicant
- Markets registered in
- 314 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Debo Medical Technology (Shijiazhuang) 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 | Debo Medical Technology (Shijiazhuang) Co., Ltd. | 63 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Debo Medical Technology (Shijiazhuang) Co., Ltd. | 13 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Debo Medical Technology (shijiazhuang) 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 Debo Medical Technology (Shijiazhuang) 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | ligature tie gunOrthodontic accessories | 2026 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Mouthpiece, Saliva Ejector | 2026 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Dental Drills | 2026 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Arch Wire | 2026 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental needlesDispensing TipPre-Bent Needle Tip | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | dental hand instrumentDental InstrumentsDental ToolsResin Conveyor | 2026 |
| Amalgam Dental CapsuleDZS · Class 1 | — | Maker | dental amalgam capsule | 2026 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental Mouth MirrorDisposable Dental Instrument KitMIRROR. MOUTHOral Observer (Intraoral Endoscope) | 2026 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | MATERIAL, IMPRESSION TRAY, RESIN | 2026 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | UNIT, SUCTION OPERATORY | 2026 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air-Water Syringe TipAir/Water Syringe UnitOral Cavity Suction Device | 2026 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Arch WirebandageElastane Chainelastic materialligature tieOrthodontic bandsorthodontic elastic rubber chainOrthodontic Elasticsorthodontic suppliesSeparator Elastormeric | 2026 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | dental banddental modelDental Polishing Brushelastic chainelastic materialligature tieorthodontic archwireorthodontic bandorthodontic bracketorthodontic buccal tube 6 moreorthodontic elastic materialorthodontic kitorthodontic suppliespolishing brushprobe (forceps)separator elastomer | 2026 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Springs | 2026 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | INSTRUMENT, LIGATURE TUCKINGORTHODONTIC | 2026 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | led light curing unitLIGHT SOURCE FOR BLEACHING TEETHSmart Teeth Whitening DeviceTeeth Whitening LED LightTeeth Whitening LightToothwhitening Kit | 2026 |
| Articulation PaperEFH · Class 1 | — | Maker | articulating paperPAPER, ARTICULATION | 2026 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | dental forceps | 2026 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | disposable dental kitDisposable dental tweezer | 2026 |
| Roll CottonEFN · Class 1 | — | Maker | COTTON BALLSCOTTON PADSCotton Rolls | 2026 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | ORAL FLUSHERS Oral irrigation | 2026 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Cleaning Tablet | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Interdental BrushManual ToothbrushMicro-needle TipToothbrushToothbrush HeadToothbrush Head with Handle | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | WAX, DENTAL,INTRAORAL | 2026 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Complete Dental X-ray Film Positioning SystemDental X-ray Film BracketX-ray Film Holder | 2026 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | alcohol lampCUP,PROPHYLAXISdental brush / prophylactic brushdental cupglass mortar and pestlenon-stick mixing cupplastic mortar and pestlepreventive anglepreventive measuresProphy Cup BrushPolishing Cup | 2026 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | air/ water tipsDental irrigation syringe 3-WAY AIR WATER SYRINGE TIPevacuation tipsHigh Volume HVE Tipshigh-volume evacuation (HVE) tiporal cavitysuction devicesurgical tips3-Way Air Water Syringe Tip | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | CanalPro Colored SyringeDental Irrigation SyringeDental NeedleEndodontic Treatment UseIrrigation UseMixing TipPeriodontal & Endodontic Irrigation SyringePeriodontal Care UsePre-bent Needle TipSyringe | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Restorative and Impression Material SyringeTHE INJECTION OF SLILCON RUBBER | 2026 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental DamDental Gum DamGingival Protection GelGum Protector Gel | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Accessories, Retractor, Dental-Mouth PropMouth Prop | 2026 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractor, All Types -Cheek Retractor | 2026 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Dental measuring ruler | 2026 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental Probeperiodontal probe | 2026 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | dental instrument handle | 2026 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | FRAME,RUBBER DAM | 2026 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | chewable tabletsmetal bracesmetal orthodontic appliancemetal orthodontic bracketorthodontic applianceorthodontic bracketORTHODONTIC KITOrthodontic Metal Brackets, Ceramic Bracket, Self-Ligating Brackets, Metal V-slot Brackets, Orthodontic bracketsorthodontics | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Bur | 2026 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | POLISHING AGENT | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | dental abrasivedental polishing pasteProphy paste,Polishing Paste | 2026 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Tofflemire Matrix Bands | 2026 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | Operative Amalgam Carrier | 2026 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Endodontic Root Canal Plug | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points | 2026 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | dental marking pendental paperroot canal therapy-absorbent paper points | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | dental pulpdental pulp cavityEndo Fileendodontic root canal fileroot canal fileRoot Canal Files/Supper C Root Canal Files | 2026 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Dental Plastic edge | 2026 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Screw Post | 2026 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | denture cleaner | 2026 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss Box, Dental Floss Holder, Dental Floss PickDental floss, Power Flosser, Interdental Brush, Dental Flosspick/Tooth Pick Flossrubber toothpick, Soft Pick | 2026 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic pliers | 2026 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | dental bibsDenture CushionsPatient Bibs | 2026 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Ring, Teething, Fluid-Filled | 2026 |
| Carboxymethylcellulose Sodium (40-100&) Denture AdhesiveKOQ · Class 1 | — | Maker | Adhesive,Denture,Carboxymethylcellulose Sodium | 2026 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Micro Applicator Brush, Mikxing Wells, micro applicator brush | 2026 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue Scraper | 2026 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Dione Cold Light Tooth Whitening Instrument, Enamel Care/Colour Corrector/Hyaluronic SerumTeeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GELTeeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials | 2026 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | Baby TeetherNon-Fluid Filled TeetherSilicone Teethersilicone teether toy | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Blunt tip dispensing needle, scanbody, analogdental implantfiber implantroot canal therapy / root canal treatment | 2026 |
| Over the Counter Wax Impregnated Cotton Denture Pad CushionNKJ · Class 1 | — | Maker | cushion / linerdentureover-the-counter productpadwax-impregnated cotton cloth | 2026 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dental bibs clipDental CameraDisposable Cups, Universal Barrier Film, Universal Barrier Film Dispenser | 2026 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | dental chair without operating unit | 2026 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Dental kit, Denture cleansing tablets, Tooth Cleanser, Denture, Denture Cleanser, Cleaning tablets, Mouthwash TabletsDental sealing machine | 2026 |
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 |
|---|---|---|
| DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD.FDA reg. 3043648115 | Shijiazhuang Hebei, China | Contract manufacturer, Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094976). 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.