SHENZHEN DENCO MEDICAL CO., LTD.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3011554142

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
3011554142
FEI Number
3011554142
Entity Name
SHENZHEN DENCO MEDICAL CO., LTD.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
Rm 3108, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist,, Shenzhen Guangdong 518129, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
SHENZHEN DENCO MEDICAL CO., LTD. (Owner Number: 10048487)
Owner / Operator Contact Address
Rm 3108, 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

Absorbent Paper Points Molar Bands Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit Orthodontic Wax (dental)needle, Root Canal Irrigation Needle Arch Wire/Straight Wires/ Dental Lab Materials – Brass Dowel pins Dental Dam Frame, Dental Dam Heavy, Dental Dam System, Dental Dam Clamp, Dental Dam Punch, Dental Forceps, Dental Dam Punching Template, Dental Dam Sterilization container Rubber Dam, Rubber dam accessories (Rubber Dam Clamp), Rubber Dam Instrument Kit Dental Dam Clamp Tray, Polishing Disc/Polishing Strips/Polishing Cup/Polishing Coat matrix bands,Reel Matrix System, Reel Matrices, Sectional Contoured Metal Matrices, Rectangular Matrix Bands Saddle Contoured Metal Matrices Universal Kit for Premolars,Matrix Ring, Matrix Bands, Sectional Matrix system, Metal Matrix Strips, matrices Obturation pen, Obturation Pen, Obturation Gun Impression trays/trays EMATE Polisher Dental Screw Post, Fibre Post, Glass Fibre post, Glass Fibre post Kit, Screw post, Orthodontic Microimplant Dental Microscope Springs Dental Extraoral Suction unit Straight Drills for Fibre Post Drills for Screw Post Gate Drills,Peeso Reamers,Drills for dental post,Drills for fibre post Trephine Drills, Shapping Reamers Taper Drills for Fibre Post Drills for Tapered Screw Post Drills for Ouro Post Endo Enlarger Photographic Mirrors/mouth mirror; Defogging mouth mirror Micro Mirror,Oral Mirror Dental X-Ray holder Barbed Broaches Square Broaches Vacuum Former saw blade/Pindex/crucible/ Dental Implant Instruments, Implant Locator, implant Wrench, Implant stability tester Kite Gold(Kite Gold Glider, Kite Gold Shaper, Kite Gold Finisher,Kite Gold Larger, Kite Gold Assorted ), K-ENDO Micro Shaper Microscope H-Files Microscope Reamers NC PT Microscope H-Files with replaceable handle Nickel Titanium C+ Files NC FLEXI Microscope Reamers with replaceable handle NiTi Hand Use Files; Stainless Steel K Files/H Files/Reamers; NiTi K Files/H Files/Reamers; Files holder; C+ Files, U Files; Microscope Files; PRE-SHAPER; SUPER FILES; PRO-PATH; D-FILES; PRIMARY FILES (KIDS FILES); PA-FILES; SUPER FILES II) C Plus files; PD files; Microscope File Holder; Smart files holder NiTi Rotary Files (SUPER FILES III; D-SUPER FILES; D-SHAPER; PRO-FLEXI FILES; ONLY ONE FILE; W FILES; ROLL WAVE; Kibiomaster Kit, Dual shaper, FlexArc pro, BIOMASTER KIT, Tide File, Tide+ File, AJ File, AJ+ File, Kite Files PR Files Stainless Steel C+ Files DR PRO FILES NC PT+ Microscope K Files with replaceable handle DR Files R+File Nickel Titanium Reamers Micro Prober Hand Use Super Files Microscope C+ Files with replaceable handle ELITE GC Microscope C+ Files NC ROT MAX D Files RS Files Flexile files GC Files Nickel Titanium K-Files DK Files NC FILES Nickel Titanium H-Files Fire Files NC RETX NC PRO Microscope K-Files HS Files M Files PROPHY ANGLES Gutta Percha Cutter Gutta Percha Points Microscope paste carriers additional parts, Microscope paste carriers super floss, Gutta-Percha Obturation System; Microscope Paste Carriers Paste Carriers dental magnifier Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics, Elastane chain Micro Applicator LED Curing light cutting machine articulators/flask Dental Burs(Diamond Burs/Carbide Burs), Endo Disinfection Box/Holder, Rubber Diamond Polisher Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones Root Canal Irrigation Needles; Metal Matrix Strips Endo Motor, matrices, Endo Extractor Orthodontic Pliers tweezers Buccal Tubes Mixing Tips Ligature Gun Endo Block/Endo Ruler/Endo Gauge

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2015-01-19
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2018-12-02
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2023-11-22
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2018-12-02
DZM Needle, Dental Dental Class 1 872.4730 2015-03-03
DZC Wire, Orthodontic Dental Class 1 872.5410 2018-12-02
EBL Pin, Retentive And Splinting, And Accessory Instruments Dental Class 1 872.3740 2018-12-02
EIE Dam, Rubber Dental Class 1 872.6300 2023-11-22
EHM Strip, Polishing Agent Dental Class 1 872.6010 2018-12-02
EKF Instrument, Contouring, Matrix, Operative Dental Class 1 872.4565 2026-01-09
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2021-12-27
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2018-12-02
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2017-11-30
EKJ Burnisher, Operative Dental Class 1 872.4565 2024-12-13
ELR Post, Root Canal Dental Class 1 872.3810 2015-03-03
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2023-11-22
ECO Spring, Orthodontic Dental Class 1 872.5410 2018-12-02
EBR Unit, Suction Operatory Dental Class 1 872.6640 2020-05-01
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2015-01-19
EAX Mirror, Mouth Dental Class 1 872.4565 2018-12-02
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2023-11-22
EKW Broach, Endodontic Dental Class 1 872.4565 2015-03-03
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2018-12-02
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-12-02
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2015-01-19
EHK Cup, Prophylaxis Dental Class 1 872.6290 2024-12-13
EKM Gutta-Percha Dental Class 1 872.3850 2021-12-27
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2024-12-13
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2018-12-02
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2018-12-02
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2018-12-02
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2015-01-19
EAZ Light, Operating, Dental Dental Class 1 872.4630 2018-12-02
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2018-12-02
EJP Articulators Dental Class 1 872.3150 2018-12-02
EJL Bur, Dental Dental Class 1 872.3240 2015-03-03
DZN Instruments, Dental Hand Dental Class 1 872.4565 2017-11-30
JEX Plier, Orthodontic Dental Class 1 872.4565 2018-12-02
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2018-12-02
DZD Tube, Orthodontic Dental Class 1 872.5410 2018-12-02
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2018-12-02
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2018-12-02
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2018-12-02

Official Correspondent

Yongjun Xia

US Agent Details

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

Related Public Records

Same Entity

SHENZHEN DENCO 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
K112640 Ormco Corp. HYPERELASTIC WIRE 2011-11-16
K040797 Britesmile, Inc. BRITESMILE MASKING CREAM 2004-04-02
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06
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.

Similar Registrations

Registration Number Establishment Name Location
3004133229 TIANJIN DIADENT CO., LTD. TIANJIN CITY, CN
2086043 PAC-DENT INC. Brea, CA, US
3012996495 VIARDEN LAB LLC Mission, TX, US
2024312 Kerr Corporation ORANGE, CA, US
3043648115 DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD. Shijiazhuang Hebei, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011554142. Last updated year: 2026. Please use registration number 3011554142 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.