SHENZHEN ROGIN MEDICAL CO., LTD

FDA Device Registration & Listing · shenzhen Guangdong, CN · Registration 3015136927

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015136927
FEI Number
3015136927
Entity Name
SHENZHEN ROGIN MEDICAL CO., LTD
City/State/Country
shenzhen Guangdong, CN
Establishment Address
Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist, shenzhen Guangdong 518129, CN
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
SHENZHEN ROGIN MEDICAL CO., LTD (Owner Number: 10058732)
Owner / Operator Contact Address
Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist, Shenzhen, CN-GD 518129, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

cutting machine PROPHY ANGLES saw blade/Pindex/crucible, Dental Implant Instruments, Implant Locator, implant Wrench, Implant stability tester Apex Locator Impression trays/trays Sectional Contoured Metal Matrices, Rectangular Matrix Bands,Coat matrix bands, Matrix Ring, Matrix Bands, Sectional Matrix system, Metal Matrix Strips Reel Matrix System, Reel Matrices, Saddle Contoured Metal Matrices Universal Kit for Premolars, Obturation pen, Obturation Pen, Obturation Gun Infinity Endo Obturation Gun Infinity Endo Obturation Pen Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit dental magnifier Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges Dental Extraoral Suction unit Infinity Endo File Removal Kit DIAMOND BURS tweezers E-LITE Polisher Gutta Percha Cutter, Gutta Percha Obturator Orthodontic Wax LED Curing light Infinity Endo Curing Light Peeso Reamers Drills for dental post Drills for fibre post Gate Drills Dental Microscope Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones Dental Burs(Diamond Burs/Carbide Burs), Rubber Diamond Polisher, Rubber Diamond Polisher Infinity Endo Diamond Burs Endo Block, Endo Ruler, Endo Gauge, Resin Block (dental)needle, Root Canal Irrigation Needle Vacuum Former Absorbent Paper Points Infinity Endo Blue Files Microscope Reamers, Microscope C+ Files, NiTi Hand Use Files, NiTi K Files/H Files/Reamers, Stainless Steel K Files/H Files/Reamers Files holder, C+ Files, U Files, Microscope Files NiTi Rotary Files (Entrance File; Vari-Taper File; Retreatment Files; SUP-Taper File; Blue HA Sup-Taper Files; Super Flexi Files); EZ SHAPER, EZ, R-Shaper, Ino-shaper Files, C Pro Files, PF Files, Micro-Prober, Micro-Shaper, Infinity Endo Retreatment Files Infinity Endo Hedstrom Files Gold HA Sup-Taper files; Wave File; Recip-one file; Multi-taper files; Sup-Taper Next; Pre-shaper Files; Hero-S Files; VET REAMERS, Super Flexi Files Gold, Super Flexi Files Blue, TRI-SHAPE FILES, T-TAPER FILES, UC FILES, Wave File, Wave File Gold HA, Wave File Blue HA, PRIMARY Files, Infinity Endo Ultra Conservative Files R-SHAPER Files, R-SHAPER Files blue, Recip-One Files, U Files, Hero-S Files, Multi Taper Files, Entrance Files, Vari-Taper Files, R-SHAPER Files(aurora version), Ino-Shaper Files (aurora version), Sup-taper files (aurora version), Super Flexi Files (aurora version), Stainless Steel C+ Files, Stainless Steel C PRO Files, Stainless Steel Flexi Files, Microsope K-Files, Microscope H-Files, Micro-opener, Square Broaches, K-Flexi Files, DK-Files, Fire-Files, Pro-path Files, Sup-path Files, Sup-Taper Files Next BLUE, Sup-Taper Files Next Gold, Endo Training Kit, Niti Spreader, Niti Plugger PD FILES, VET K Files, VET H Files, VET REAMERS, Sup-Taper Files Gold HA, Sup-Taper Files Blue HA, Sup-Taper Files HA, T-PATH FILES, R-PROC FILES, SUP-PATH FILES, Hand Use Super Files, Nickel Titanium K-Files, SUP-PATH PRO, 3D-Flexi Shaper files, TS ELITE-Glider, TS ELITE Files, Apical shapers, Patency Finder, PF Files, Nickel Titanium H-Files, Nickel Titanium Reamers, Vet Endo Rotary Files, Access Files, Shapping Reamers, Retreatment Files, Infinity Endo C Files Ino-Shaper Files Blue, Ino-Shaper Files Gold, Infinity Endo Stainless Steel K files Micro-Prober, Micro-Shaper, Endo Training Kit Infinity Endo Gold Files Infinity Endo Coronal Shaper Gold Files Nickel Titanium C+ Files, Nickel Titanium C PRO Files, Revone Files, Acer Files, Sone Files, GC Files, Recip-One Files BLUE, Recip-One Files Gold, Sup-Taper Files Next, Nickel Titanium Flexi Files , VET K Files, VET H Files, EZ Shaper, EZ Shaper PRO, UNI-SHAPE Files, SF-SHAPE FILES, Infinity Endo Coronal Shaper Blue Files Stainless Steel K-Files, Stainless Steel H-Files, Stainless Steel Reamers, Molar Bands Dental X-Ray holder Fibre Post, Dental Screw Post, Orthodontic Microimplant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2018-10-24
EHK Cup, Prophylaxis Dental Class 1 872.6290 2024-12-13
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-10-24
LQY Locator, Root Apex Unknown Class U N/A 2025-03-24
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2018-10-24
EKF Instrument, Contouring, Matrix, Operative Dental Class 1 872.4565 2026-01-13
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2021-12-23
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2023-11-22
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2018-10-24
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2018-10-24
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2026-01-13
EBR Unit, Suction Operatory Dental Class 1 872.6640 2020-05-01
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2025-09-15
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2018-10-24
EKJ Burnisher, Operative Dental Class 1 872.4565 2024-12-13
EKM Gutta-Percha Dental Class 1 872.3850 2018-10-24
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2018-10-24
EAZ Light, Operating, Dental Dental Class 1 872.4630 2018-10-24
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2018-10-24
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2023-11-22
EJL Bur, Dental Dental Class 1 872.3240 2018-10-24
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2018-10-24
DZM Needle, Dental Dental Class 1 872.4730 2018-10-24
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2018-10-24
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2018-10-24
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2018-10-24
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2018-10-24
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2023-11-22
ELR Post, Root Canal Dental Class 1 872.3810 2018-10-24

Official Correspondent

Xiaoran Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

SHENZHEN ROGIN MEDICAL CO., LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015136927. Last updated year: 2026. Please use registration number 3015136927 when referencing this establishment in official correspondence.
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