ZOGEAR Medical Co., Ltd.

FDA Device Registration & Listing · Yizheng Jiangsu, CN · Registration 3010583458

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
3010583458
FEI Number
3010583458
Entity Name
ZOGEAR Medical Co., Ltd.
City/State/Country
Yizheng Jiangsu, CN
Establishment Address
No.166, Industrial Concentration Area, Dayi Town, Yizheng Jiangsu 211400, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ZOGEAR Medical Co., Ltd. (Owner Number: 10045283)
Owner / Operator Contact Address
No.166, Industrial Concentration Area, Dayi Town, Yizheng, CN-JS 211409, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HANDLE, INSTRUMENT, DENTAL INSTRUMENT, CONTOURING, MATRIX, OPERATIVE Tube mount, x-ray, diagnostic Gauze/sponge,nonresorbable for external use HYDRAZONE COLORIMETRY, ALT/SGPT Dental Disposable Fluoride Tray ACCESSORY, SURGICAL APPAREL gloves Cleaning Tablet Pill crusher/cutter DRESS, SURGICAL CONNECTOR, CATHETER Cleanser, denture, prescription INSTRUMENT, HAND, CALCULUS REMOVAL INSTRUMENTS, DENTAL HAND Ovulation test strip Tongue scraper PAPER, ARTICULATION Electric Dental Water Flosser CHAIR, DENTAL, WITHOUT OPERATIVE UNIT BAND, PREFORMED, ORTHODONTIC BAND, ELASTIC, ORTHODONTIC ZINC OXIDE EUGENOL Device, digital image storage, radiological INSTRUMENT, MANUAL, SURGICAL, GENERAL USE CONTAINER, SPECIMEN, NON-STERILE Mouthpiece, saliva ejector UTENSIL, EATING SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC CONTAINER, LIQUID MEDICATION, GRADUATED FORCEPS, ARTICULATION PAPER FLOSS, DENTAL MASK, SCAVENGING FILE, PULP CANAL, ENDODONTIC SHOE AND SHOE COVER, CONDUCTIVE MIRROR, MOUTH Film, radiographic protective coverall, isolation coverall WAX, DENTAL, INTRAORAL INSTRUMENT, FILLING, PLASTIC, DENTAL POST, ROOT CANAL POINT, PAPER, ENDODONTIC VAGINAL APPLICATOR CAP, SURGICAL Shield, protective, personnel EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE TRAY, SURGICAL TOOTHBRUSH, MANUAL CUSHION, PAD, DENTURE, WAX IMPREGNATED COTTON, OVER THE COUNTER Shield, eye, ophthalmic,face shield,eyewear,face&eye protector INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC CanalPro color syringes SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING Catheter COTTON, ROLL Surgical Masks Disposable Medical Masks Dental Bib BLADE, SCALPEL NEEDLE, DENTAL CanlPro Tips PROBE, PERIODONTIC UNIT, SYRINGE, AIR AND/OR WATER HANDLE, SCALPEL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2013-11-15
EKF Instrument, Contouring, Matrix, Operative Dental Class 1 872.4565 2013-11-17
IYB Tube Mount, X-Ray, Diagnostic Radiology Class 1 892.1770 2013-11-17
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2013-11-18
CKD Hydrazone Colorimetry, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2013-11-03
KMT Tray, Fluoride, Disposable Dental Class 1 872.6870 2025-02-12
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2013-11-18
EFT Cleanser, Denture, Over The Counter Dental Class 1 872.3520 2025-05-22
OHY Pill Crusher/Cutter General Hospital Class 1 880.6430 2013-11-18
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2013-11-17
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2013-11-17
NUX Cleanser, Denture, Prescription Dental Class 1 872.3520 2013-11-18
ELA Instrument, Hand, Calculus Removal Dental Class 1 872.4565 2013-11-17
DZN Instruments, Dental Hand Dental Class 1 872.4565 2013-11-15
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2025-09-12
LCN Scraper, Tongue Dental Class 1 872.6855 2025-05-22
EFH Paper, Articulation Dental Class 1 872.6140 2013-11-15
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2026-03-31
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2015-11-04
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2016-07-18
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2013-11-15
EMB Zinc Oxide Eugenol Dental Class 1 872.3275 2013-11-17
LMB Device, Digital Image Storage, Radiological Radiology Class 1 892.2010 2013-11-17
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-11-10
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2013-11-18
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2013-11-11
ILC Utensil, Eating Physical Medicine Class 1 890.5050 2013-11-17
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 2013-11-17
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2013-11-17
EFK Forceps, Articulation Paper Dental Class 1 872.4565 2013-11-15
JES Floss, Dental Dental Class 1 872.6390 2013-11-17
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2013-11-17
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2013-11-17
BWP Shoe And Shoe Cover, Conductive General, Plastic Surgery Class 1 878.4040 2013-11-10
EAX Mirror, Mouth Dental Class 1 872.4565 2013-11-15
IWZ Film, Radiographic Radiology Class 1 892.1840 2013-11-17
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-27
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2013-11-15
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2013-11-15
ELR Post, Root Canal Dental Class 1 872.3810 2013-11-17
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2013-11-17
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2025-09-12
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2013-11-17
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2013-11-17
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2013-11-18
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-11-18
EFW Toothbrush, Manual Dental Class 1 872.6855 2013-11-15
NKJ Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter Dental Class 1 872.3540 2013-11-18
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2013-11-17
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2013-11-15
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2013-11-15
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2016-07-18
EFN Cotton, Roll Dental Class 1 872.6050 2013-11-10
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2020-06-05
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2021-05-15
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2013-11-17
DZM Needle, Dental Dental Class 1 872.4730 2013-11-15
EIX Probe, Periodontic Dental Class 1 872.4565 2013-11-15
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2013-11-15
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2013-11-17

Official Correspondent

Yongmei Yan

US Agent Details

James St. WU Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

ZOGEAR 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
K902838 Denture Dynamic'S, Inc. DENTURE DYNAMIC'S DENTURE MAGIC 1990-09-06
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04
K882164 Arthur Blank & Co., Inc. FLOSS CARD 1988-06-10
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01
Z-0012-2012 Biomet Microfixation, Inc. 1
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010583458. Last updated year: 2026. Please use registration number 3010583458 when referencing this establishment in official correspondence.
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