Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017910185

FEI Number

3017910185

Entity Name

HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Wuhan Hubei, CN

Establishment Address

Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District, Wuhan Hubei 430070, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hubei Guarddent Medical Technology Co.,Ltd (Owner Number: 10078958)

Owner / Operator Contact Address

Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District, Wuhan City, CN-HB 430070, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blade Pre Bent Needle Tips, Mixing Tips, irrigation syringe,dental needle lmpression Syringe Hygienic Finger Cots Gingival drainage Orthodontic Brackets Dental block Dental Floss Articulating Paper Tongue depressor Absorbent paper points surgical gowns face masks Fiber Post Nonwoven Gauze lsolation Gowns, Surgical Gown Face Shield disposable sheet High Volume HVE Tips Patient Bibs Dental Wax rubber dam Orthodontic Arch Wire Saliva Ejectors Dental Barrier and Sleeves Barrier covers, Barrier film Prophy angle/cup/brush Dental needle Barrier Film Dispenser, Cotton Rolls Dispenser Cohesive tape/self adhesive bandage wrap Orthodontic Rubber Chain and Ligature Tie Retainer Box,Denture box Phosphor Plate Endo file Impression Trays, Bite Registration Tray denture teeth Air Water Syringe Tips Micro Applicator Brush, Mixing Wells Mouth Prop Plastic Instrument Trays

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-11-30
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2020-11-12
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2020-11-12
LZB	Finger Cot	General Hospital	Class 1	880.6250	2024-05-28
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2026-02-26
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-11-28
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2023-12-19
JES	Floss, Dental	Dental	Class 1	872.6390	2024-11-28
EFH	Paper, Articulation	Dental	Class 1	872.6140	2024-11-28
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2023-09-27
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2023-09-27
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-12-10
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-12-10
ELR	Post, Root Canal	Dental	Class 1	872.3810	2024-11-28
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-11-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-11-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-11-12
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-11-23
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2020-11-12
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2020-11-12
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-11-28
EIE	Dam, Rubber	Dental	Class 1	872.6300	2026-02-26
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-11-28
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2020-11-12
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2026-05-19
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2020-11-12
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2022-11-23
DZM	Needle, Dental	Dental	Class 1	872.4730	2021-11-30
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2020-11-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-11-23
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-11-28
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-11-12
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2025-12-10
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2023-09-27
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2020-11-12
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2020-11-12
KXR	Applicator, Resin	Dental	Class 1	872.3140	2020-11-12
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2020-11-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-11-12

Official Correspondent

Qin Hu

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Hubei Guarddent Medical Technology 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
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 307850DISTRIBUTED 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 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017910185. Last updated year: 2026. Please use registration number 3017910185 when referencing this establishment in official correspondence.