Manufacturer registered with FDA
Shenzhen Rogin Medical Co., Ltd.
Shenzhen, China. Lists 43 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 43
- Brands and models
- 113
- 510(k) clearances
- 12025–2025
- Markets registered in
- 111,250 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Shenzhen Rogin 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 Rogin Medical Co., Ltd. | 1 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Rogin Medical Co., Ltd | 1,158 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SHENZHEN ROGIN MEDICAL CO., LTD | 35 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHENZHEN ROGIN MEDICAL CO., LTD.SHENZHEN ROGIN MEDICAL CO. LTD · SHENZHEN ROGIN MEDICAL CO LTD | 17 | 2020–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shenzhen Rogin Medical Co., Ltd. | 13 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SHENZHEN ROGIN MEDICAL CO., LTDShenzhen Rogin Medical Co., Ltd · SHENZHEN ROGIN MEDICAL Co.,LTD | 12 | 2017–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHENZHEN ROGIN MEDICAL CO., LTDSHENZHEN ROGIN MEDICAL CO., LTD. | 6 | 2018–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Shenzhen Rogin Medical Co., Ltd.Shenzhen Rogin Medical Co., Ltd | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHENZHEN ROGIN MEDICAL CO., LTD | 3 | 2025–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHENZHEN ROGIN MEDICAL CO., LTD. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Shenzhen Rogin Medical Co., Ltd. | 1 | 2025–2025 | 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 Rogin 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 dental postDrills for fibre postGate DrillsPeeso Reamers | 2018 |
| 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 | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Endo Motor, matrices, Endo ExtractorRoot Canal Irrigation Needle; Matrix Strips | 2018 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | DIAMOND BURS | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Oral MirrorPhotographic Mirrors/mouth mirror, Defogging mouth mirror | 2018 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Infinity Endo Curing LightLED 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 unitInfinity Endo File Removal Kit | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics | 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 Brushes | 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 Clamp, Dental Dam Punch, Dental Forceps,Dental Dam Frame, Dental Dam Heavy,Dental Dam Punching Template,Dental Dam Sterilization containerDental Dam System, dental dam instrument kit,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, Resin Block | 2018 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Gutta-Percha Obturation System (ELITE FILL-E); Microscope Paste CarriersMicroscope paste carriers additional partsMicroscope paste carriers super flossPaste Carriers | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Infinity Endo Obturation GunInfinity Endo Obturation PenObturation pen, Obturation Pen, Obturation Gun | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Ceramic Bracket/Metal V-slot Brackets/Orthodontic Metal Brackets/Self-Ligating Brackets/ | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs(Diamond Burs/Carbide Burs), Rubber Diamond Polisher, Rubber Diamond PolisherInfinity Endo Diamond BursSilicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones | 2018 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | articulators/flask | 2018 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Matrix Ring, Matrix Bands, Sectional Matrix system, Metal Matrix StripsReel Matrix System, Reel Matrices, Saddle Contoured Metal Matrices Universal Kit for Premolars,Sectional Contoured Metal Matrices, Rectangular Matrix Bands,Coat matrix bands, | 2026 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | E-LITE Polisher | 2024 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Niti Spreader, Niti PluggerStainless Steel Spreaders/Pluggers, Gutta Percha Pluggers | 2018 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Cutter, Gutta Percha Obturator | 2018 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2018 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | DK-Files, Fire-Files, Pro-path Files, Sup-path Files,Endo Training Kit, Niti Spreader, Niti PluggerEZ Shaper, EZ Shaper PRO, UNI-SHAPE Files, SF-SHAPE FILES,Files holder, C+ Files, U Files, Microscope FilesGold HA Sup-Taper files; Wave File; Recip-one file; Multi-taper files; Sup-Taper Next; Pre-shaper Files; Hero-S Files;Hand Use Super Files, Nickel Titanium K-Files,Infinity Endo Blue FilesInfinity Endo C FilesInfinity Endo Coronal Shaper Blue FilesInfinity Endo Coronal Shaper Gold Files 34 moreInfinity Endo Gold FilesInfinity Endo Hedstrom FilesInfinity Endo Retreatment FilesInfinity Endo Stainless Steel K filesInfinity Endo Ultra Conservative FilesIno-Shaper Files Blue, Ino-Shaper Files Gold,Micro-opener, Square Broaches, K-Flexi Files,Micro-Prober, Micro-Shaper, Endo Training KitMicroscope Reamers, Microscope C+ Files,Microsope K-Files, Microscope H-Files,Nickel Titanium C+ Files, Nickel Titanium C PRO Files,Nickel Titanium Flexi Files , VET K Files, VET H Files,Nickel Titanium H-Files, Nickel Titanium Reamers,NiTi Hand Use Files, NiTi K Files/H Files/Reamers, Stainless Steel K Files/H Files/ReamersNiTi Rotary Files (Entrance File; Vari-Taper File; Retreatment Files; SUP-Taper File; Blue HA Sup-Taper Files;PD FILES, VET K Files, VET H Files, VET REAMERS,R-SHAPER Files, R-SHAPER Files blue, Recip-One Files,R-SHAPER Files(aurora version), Ino-Shaper Files (aurora version),Recip-One Files BLUE, Recip-One Files Gold, Sup-Taper Files Next,Revone Files, Acer Files, Sone Files, GC Files,Stainless Steel C+ Files, Stainless Steel C PRO Files, Stainless Steel Flexi Files,Stainless Steel K-Files, Stainless Steel H-Files, Stainless Steel Reamers,SUP-PATH PRO, 3D-Flexi Shaper files, TS ELITE-Glider,Sup-taper files (aurora version), Super Flexi Files (aurora version),Sup-Taper Files Gold HA, Sup-Taper Files Blue HA, Sup-Taper Files HA,Sup-Taper Files Next BLUE, Sup-Taper Files Next Gold,Super Flexi Files); EZ SHAPER, EZ, R-Shaper, Ino-shaper Files, C Pro Files, PF Files, Micro-Prober, Micro-Shaper,T-PATH FILES, R-PROC FILES, SUP-PATH FILES,TRI-SHAPE FILES, T-TAPER FILES, UC FILES,TS ELITE Files, Apical shapers, Patency Finder, PF Files,U Files, Hero-S Files, Multi Taper Files, Entrance Files, Vari-Taper Files,Vet Endo Rotary Files, Access Files, Shapping Reamers, Retreatment Files,VET REAMERS, Super Flexi Files Gold, Super Flexi Files Blue,Wave File, Wave File Gold HA, Wave File Blue HA, PRIMARY Files, | 2018 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | Barbed Broaches, Barbed BroachesSquare Broaches | 2018 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | 2025 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Fibre Post, Dental Screw Post, Orthodontic Microimplant | 2018 |
| 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 ROGIN MEDICAL CO., LTDFDA reg. 3015136927 | shenzhen Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058732). 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.