Shenzhen Rogin Medical Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 51 device types, 2 products catalogued, 2 clearances.
Shenzhen Rogin Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dermatome, Bur, Dental and 49 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
51device types registered with the FDA
2products catalogued under its own name
2510(k) clearances
Registration
| Registered name | SHENZHEN ROGIN MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015136927 |
| FEI number | 3015136927 |
| DUNS | 551138557 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市乐捷医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Rm 3109, Bldg 6, Tian’an Cloud Park, Bantian Str, Longgang Dist |
| Postal code | 518129 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | saw blade/Pindex/crucible, Dental Implant Instruments, Implant Locator, implant Wrench, Implant stability tester | 2018 | 70 |
| Accessories, Retractor, Dental | Class 1 | Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges | 2026 | 37 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Micro Applicator | 2018 | 186 |
| Articulators | Class 1 | articulators/flask | 2018 | 7 |
| Band, Elastic, Orthodontic | Class 1 | Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics | 2018 | 36 |
| Band, Preformed, Orthodontic | Class 1 | Molar Bands | 2018 | 27 |
| Bone Particle Collector | Class 1 | Dust Collector | 2018 | 2 |
| Bracket, Metal, Orthodontic | Class 1 | Self-Ligating Brackets/, Metal V-slot Brackets/, Orthodontic Metal Brackets/, Ceramic Bracket/ | 2018 | 52 |
| Broach, Endodontic | Class 1 | Square Broaches, Barbed Broaches, Barbed Broaches | 2018 | 10 |
| Bur, Dental | Class 1 | Infinity Endo Diamond Burs, Dental Burs(Diamond Burs/Carbide Burs), Rubber Diamond Polisher, Rubber Diamond Polisher, Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones | 2018 | 46 |
| Burnisher, Operative | Class 1 | E-LITE Polisher | 2024 | 5 |
| Cup, Prophylaxis | Class 1 | Prophy Angles | 2024 | 49 |
| Dam, Rubber | Class 1 | Dental Dam Clamp, Dental Dam Punch, Dental Forceps,, Rubber Dam, Rubber dam accessories (Rubber Dam Clamp), Rubber Dam Instrument Kit, Dental Dam Clamp Tray,, Dental Dam Sterilization container, Dental Dam System, dental dam instrument kit,, Dental Dam Punching Template, and 1 more | 2023 | 23 |
| Dermatome | Class 1 | cutting machine | 2018 | 6 |
| Disinfector, Medical Devices | Class 2 | Root Canal Files disinfection box | 2021 | 9 |
| Drill, Dental, Intraoral | Class 1 | Gate Drills, Drills for fibre post, Peeso Reamers, Drills for dental post | 2018 | 20 |
| Epilator, High Frequency, Tweezer-Type | Class 1 | Vibrator | 2018 | 13 |
| Evacuator, Oral Cavity | Class 1 | Vacuum Former | 2018 | 49 |
| File, Pulp Canal, Endodontic | Class 1 | Hand Use Super Files, Nickel Titanium K-Files,, Infinity Endo Coronal Shaper Gold Files, Infinity Endo Hedstrom Files, TS ELITE Files, Apical shapers, Patency Finder, PF Files,, R-SHAPER Files, R-SHAPER Files blue, Recip-One Files,, Stainless Steel C+ Files, Stainless Steel C PRO Files, Stainless Steel Flexi Files, and 38 more | 2018 | 53 |
| Forceps, Dressing, Dental | Class 1 | tweezers | 2018 | 22 |
| Gauge, Depth, Instrument, Dental | Class 1 | Endo Block, Endo Ruler, Endo Gauge, Resin Block | 2018 | 10 |
| Gutta-Percha | Class 1 | Gutta Percha Cutter, Gutta Percha Obturator | 2018 | 42 |
| Handle, Instrument, Dental | Class 1 | Obturation pen, Obturation Pen, Obturation Gun, Infinity Endo Obturation Gun, Infinity Endo Obturation Pen | 2021 | 29 |
| Handpiece, Direct Drive, Ac-Powered | Class 1 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | 2025 | 10 |
| Holder, Film, X-Ray | Class 1 | Dental X-Ray holder | 2023 | 40 |
| Instrument, Contouring, Matrix, Operative | Class 1 | Matrix Ring, Matrix Bands, Sectional Matrix system, Metal Matrix Strips, Sectional Contoured Metal Matrices, Rectangular Matrix Bands,Coat matrix bands,, Reel Matrix System, Reel Matrices, Saddle Contoured Metal Matrices Universal Kit for Premolars, | 2026 | 10 |
| Instrument, Diamond, Dental | Class 1 | Diamond Burs | 2025 | 7 |
| Instrument, Filling, Plastic, Dental | Class 1 | Gutta-Percha Obturation System (ELITE FILL-E); Microscope Paste Carriers, Microscope paste carriers super floss, Paste Carriers, Microscope paste carriers additional parts | 2024 | 23 |
| Instrument, Ligature Tucking, Orthodontic | Class 1 | Ligature Gun | 2018 | 10 |
| Instruments, Dental Hand | Class 1 | Endo Motor, matrices, Endo Extractor, Root Canal Irrigation Needle; Matrix Strips | 2018 | 64 |
| Light, Operating, Dental | Class 1 | LED Curing light, Infinity Endo Curing Light | 2018 | 16 |
| Locator, Root Apex | Class U | Apex Locator | 2025 | 8 |
| Loupe, Diagnostic/Surgical | Class 1 | dental magnifier | 2018 | 15 |
| Microscope, Surgical | Class 1 | Dental Microscope | 2023 | 9 |
| Mirror, Mouth | Class 1 | Oral Mirror, Photographic Mirrors/mouth mirror, Defogging mouth mirror | 2018 | 94 |
| Needle, Dental | Class 1 | (dental)needle, Root Canal Irrigation Needle | 2018 | 56 |
| Pin, Retentive And Splinting, And Accessory Instruments | Class 1 | Dental Lab Materials → Brass Dowel pins | 2018 | 4 |
| Plier, Orthodontic | Class 1 | Orthodontic Pliers | 2018 | 28 |
| Point, Paper, Endodontic | Class 1 | Absorbent Paper Points | 2018 | 35 |
| Post, Root Canal | Class 1 | Fibre Post, Dental Screw Post, Orthodontic Microimplant | 2018 | 10 |
| Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | Niti Spreader, Niti Plugger, Stainless Steel Spreaders/Pluggers, Gutta Percha Pluggers | 2018 | 17 |
| Spring, Orthodontic | Class 1 | Springs | 2018 | 22 |
| Strip, Polishing Agent | Class 1 | Polishing Disc/Polishing Strips/Polishing Cup/Polishing Brushes | 2018 | 18 |
| Syringe, Irrigating (Dental) | Class 1 | Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit | 2023 | 22 |
| Syringe, Restorative And Impression Material | Class 1 | Mixing Tips | 2018 | 49 |
| Tray, Impression, Preformed | Class 1 | Impression trays/trays | 2018 | 73 |
| Tube, Orthodontic | Class 1 | Buccal Tubes/ | 2018 | 34 |
| Unit, Operative Dental, Accessories | Class 1 | compressors | 2018 | 65 |
| Unit, Suction Operatory | Class 1 | Dental Extraoral Suction unit, Infinity Endo File Removal Kit | 2020 | 23 |
| Wax, Dental, Intraoral | Class 1 | Orthodontic Wax | 2018 | 55 |
| Wire, Orthodontic | Class 1 | Arch Wire/Straight Wires | 2018 | 43 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Rogin | EKX | 3 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242514 | 2025-04-24 | EKX | Traditional | This company |
| K242383 | 2025-03-07 | LQY | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | endo files, NITI rotary files, broaches, screw posts, matrices |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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