FDA Registration
Active
🇨🇳 China
SHENZHEN DENCO MEDICAL CO., LTD.
Reg #: 3011554142
·
FEI: 3011554142
·
Expires 2026
Products
51
Proprietary Names
115
Establishment Types
4
Classifications
51
Registration Details
- Registration Name
- SHENZHEN DENCO MEDICAL CO., LTD.
- Registration Number
- 3011554142
- FEI Number
- 3011554142
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rm 3108, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist,
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- SHENZHEN DENCO MEDICAL CO., LTD.
- Operator Number
- 10048487
- Address
- Rm 3108, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518129
- Country
- CN
- Correspondent
- Yongjun Xia
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2015-01-19 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2018-12-02 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2023-11-22 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2018-12-02 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2015-03-03 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2018-12-02 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2018-12-02 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2023-11-22 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2018-12-02 |
| Instrument, Contouring, Matrix, Operative | EKF | Class 1 | Dental | No | 2026-01-09 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2021-12-27 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2018-12-02 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2017-11-30 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2024-12-13 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2015-03-03 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2023-11-22 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2018-12-02 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2020-05-01 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2015-01-19 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2018-12-02 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2023-11-22 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2015-03-03 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2018-12-02 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-12-02 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2015-01-19 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2024-12-13 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2021-12-27 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2024-12-13 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2018-12-02 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2018-12-02 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2018-12-02 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2015-01-19 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2018-12-02 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2018-12-02 |
| Articulators | EJP | Class 1 | Dental | No | 2018-12-02 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2015-03-03 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-11-30 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2018-12-02 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2018-12-02 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2018-12-02 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2018-12-02 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2018-12-02 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2018-12-02 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2018-12-02 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2017-11-30 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2015-01-19 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2026-01-09 |
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2021-12-27 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2025-09-15 |
| Bone Particle Collector | MXP | Class 1 | Ear, Nose, Throat | No | 2018-12-02 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2018-12-02 |
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
compressors
Stainless Steel Spreaders/Pluggers, Gutta Percha Pluggers, NiTi Spreaders; NiTi Pluggers
Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges
Root Canal Files disinfection box
DIAMOND BURS
Vibrator
Orthodontic Metal Brackets/Ceramic Bracket/Self-Ligating Brackets/Metal V-slot Brackets
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Sterilize Medical Device for Another Party (Contract Sterilizer)