Manufacturer registered with FDA
Shenzhen Denco Medical Co Ltd
Shenzhen, China. Lists 46 dental device types with FDA across 1 registered establishment.
- Device types listed
- 46
- Brands and models
- 110
- 510(k) clearances
- 0as applicant
- Markets registered in
- 132,747 registrations outside the US
- Establishments
- 1China
Registered in 13 markets
Where regulators' registries name Shenzhen Denco 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 | Shenzhen Denco Medical Co Ltd | 46 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Denco Medical Co., Ltd. | 2,629 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHENZHEN DENCO MEDICAL CO., LTDSHENZHEN DENCO MEDICAL CO. LTD | 32 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Shenzhen Denco Medical Co., LtdShenzhen Denco Medical Co, Ltd | 25 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHENZHEN DENCO MEDICAL CO., LTDSHENZHEN DENCO MEDICAL CO,.LTD | 15 | 2016–2024 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Shenzhen Denco Medical Co., Ltd. | 9 | 2024–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SHENZHEN DENCO MEDICAL CO., LTD | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Denco Medical Co Ltd | 7 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHENZHEN DENCO MEDICAL Co., Ltd. | 7 | 2021–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHENZHEN DENCO MEDICAL CO., LTD.SHENZHEN DENCO MEDICAL CO., LTD | 6 | 2017–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | SHENZHEN DENCO MEDICAL CO., LTDShenzhen Denco Medical Co., LTD · Shenzhen Denco Medical co. ltd | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SHENZHEN DENCO MEDICAL CO.. LTD.Shenzhen Denco Medical Co., LTD · Shenzhen Denco Medical Co., Ltd | 4 | 2024–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shenzhen Denco Medical Co. Ltd. | 1 | — | 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 Denco 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Drills for Ouro PostDrills for Screw PostDrills for Tapered Screw PostEndo EnlargerGate Drills,Peeso Reamers,Drills for dental post,Drills for fibre postStraight Drills for Fibre PostTaper Drills for Fibre PostTrephine Drills, Shapping Reamers | 2015 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Arch Wire/Straight Wires/ | 2018 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Buccal Tubes | 2018 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | (dental)needle, Root Canal Irrigation Needle | 2015 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Endo Motor, matrices, Endo ExtractorRoot Canal Irrigation Needles; Metal Matrix Strips | 2017 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | DIAMOND BURS | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Micro Mirror,Oral MirrorPhotographic Mirrors/mouth mirror; Defogging mouth mirror | 2018 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | LED Curing light | 2018 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Dental Lab Materials Brass Dowel pins | 2018 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Dental Extraoral Suction unit | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics, Elastane chain | 2018 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Molar Bands | 2018 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Springs | 2018 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Ligature Gun | 2018 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | tweezers | 2018 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic Wax | 2018 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Dental X-Ray holder | 2023 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | PROPHY ANGLES | 2024 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Polishing Disc/Polishing Strips/Polishing Cup/Polishing | 2018 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression trays/trays | 2018 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Vacuum Former | 2018 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit | 2023 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Mixing Tips | 2018 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Dam Clamp Tray,Dental Dam Frame, Dental Dam Heavy,Dental Dam Punch, Dental Forceps,Dental Dam Punching Template,Dental Dam Sterilization containerDental Dam System, Dental Dam Clamp,Rubber Dam, Rubber dam accessories (Rubber Dam Clamp), Rubber Dam Instrument Kit | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges | 2026 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Endo Block/Endo Ruler/Endo Gauge | 2018 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Gutta-Percha Obturation System; Microscope Paste CarriersMicroscope paste carriers additional parts,Microscope paste carriers super floss,Paste Carriers | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Obturation pen, Obturation Pen, Obturation Gun | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Metal Brackets/Ceramic Bracket/Self-Ligating Brackets/Metal V-slot Brackets | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs(Diamond Burs/Carbide Burs), Endo Disinfection Box/Holder, Rubber Diamond PolisherSilicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones | 2015 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | articulators/flask | 2018 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | — | 2017 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Coat matrix bands,Reel Matrix System, Reel Matrices,Matrix Bands, Sectional Matrix system, Metal Matrix Strips, matricesSaddle Contoured Metal Matrices Universal Kit for Premolars,Matrix Ring,Sectional Contoured Metal Matrices, Rectangular Matrix Bands | 2026 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | EMATE Polisher | 2024 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Stainless Steel Spreaders/Pluggers, Gutta Percha Pluggers, NiTi Spreaders; NiTi Pluggers | 2015 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha CutterGutta Percha Points | 2021 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2015 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | — | 2015 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Gutta Percha Obturation Device;Plugger;Gutta Cutter | 2026 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | C Plus files; PD files; Microscope File Holder; Smart files holderD FilesDK FilesDR FilesDR PRO FILESELITE GCFire FilesFlexile filesGC FilesHand Use Super Files 34 moreHS FilesK-ENDOKibiomaster Kit, Dual shaper, FlexArc pro, BIOMASTER KIT, Tide File, Tide+ File, AJ File, AJ+ File, Kite FilesKite Gold(Kite Gold Glider, Kite Gold Shaper, Kite Gold Finisher,Kite Gold Larger, Kite Gold Assorted ),M FilesMicro ProberMicro ShaperMicroscope C+ FilesMicroscope C+ Files with replaceable handleMicroscope H-FilesMicroscope H-Files with replaceable handleMicroscope K Files with replaceable handleMicroscope K-FilesMicroscope ReamersMicroscope Reamers with replaceable handleNC FILESNC FLEXINC PRONC PTNC PT+NC RETXNC ROT MAXNickel Titanium C+ FilesNickel Titanium H-FilesNickel Titanium K-FilesNickel Titanium ReamersNiTi Hand Use Files; Stainless Steel K Files/H Files/Reamers;NiTi K Files/H Files/Reamers; Files holder; C+ Files, U Files; Microscope Files;NiTi Rotary Files (SUPER FILES III; D-SUPER FILES; D-SHAPER; PRO-FLEXI FILES; ONLY ONE FILE; W FILES; ROLL WAVE;PR FilesPRE-SHAPER; SUPER FILES; PRO-PATH; D-FILES; PRIMARY FILES (KIDS FILES); PA-FILES; SUPER FILES II)R+FileRS FilesStainless Steel C+ Files | 2015 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | Barbed BroachesSquare Broaches | 2015 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Dental Screw Post, Fibre Post, Glass Fibre post, Glass Fibre post Kit, Screw post, Orthodontic Microimplant | 2015 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | — | 2017 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Pliers | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | saw blade/Pindex/crucible/ Dental Implant Instruments, Implant Locator, implant Wrench, Implant stability tester | 2018 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | compressors | 2018 |
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 DENCO MEDICAL CO., LTD.FDA reg. 3011554142 | Shenzhen Guangdong, China | Contract manufacturer, Contract sterilizer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048487). 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.