Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013463240

FEI Number

3013463240

Entity Name

HUANGHUA DK DENTAL CO., LTD

City/State/Country

HuangHua Hebei, CN

Establishment Address

YangSanMu Industrial Park, HuangHua Hebei 061100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HUANGHUA DK DENTAL CO., LTD (Owner Number: 10054767)

Owner / Operator Contact Address

YangSanMu Industrial Park, HuangHua, CN-HE 061100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Retractor, Mouth Props Acrylic Display Stand; Disposable Dental Instrument Kit.Medical instrument tray;Sterilising Trays Bur Holder,Cotton Roll Dispenser,Holder Of Medicine Bottle DENTURE TRANSPORTATION BOX,ENDO HOLDER; soak sterilize cup Micro Applicator Brace elastics Universal Barrier Film Dental tip safety Glasses Prebent Tips Dental needle, Prevent tips Composite Dispenser Gun,IMPRESSION DISPENSER GUN;Amalaged carrier Polish wheel, strip, brush, cup, dish anti snoring mouthpiece Cotton roll Spatula Aligner removal tool Brush Applicator Dental tip, Mixing tips Denture Box; Cotton Roll Box; Bur box; DENTURE TRANSPORTATION BOX Probe Air-Water Syringe Tip, Cover Of Air-Water Syringe Tip,Curved Utility Syringes, HP Mixing Tip Aligner chewies Mouth Mirrors Dental sectional contoured matrices; Dental sectional contoured matrices kit Mouth Props,ENDO MEASURE BLOCK,ENDO CLEAN BLOCK;ENDO Ring and Chshions Poly Wedge;wooden wedge; Silicone Rubber Mixing Tips Forcep Lung exerciser Toothbrush Orthodontic kit Protective Light Hand Shield; Medical Face Shield With Frame disposable glasses; mask with face shield; disposable face shield; Safety Glasses X-Ray Film Holder, X-Ray system, Ring; Arm, Holder Bib Clip; Cotton Roll Clips Endo Ruler; Microdont; ENDO MEASURE BLOCK; ENDO CLEAN BLOCK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2017-04-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-04-24
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-04-24
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2025-01-06
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2017-04-24
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2024-01-09
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2017-04-24
KXR	Applicator, Resin	Dental	Class 1	872.3140	2025-01-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2024-02-01
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2017-04-24
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2024-01-09
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2022-07-01
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-01-09
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-04-24
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2023-01-12
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2017-04-24
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2024-02-01
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2017-04-24
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2017-04-24
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2017-04-24
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2023-01-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2017-04-24
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2017-04-24
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2017-04-24
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2017-04-24
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2023-04-17
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-01-09
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2023-01-12
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2017-04-24
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2017-04-24
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2017-04-24
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2017-04-24

Official Correspondent

John Liu

US Agent Details

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

Related Public Records

Same Entity

HUANGHUA DK DENTAL 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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.

Similar Registrations

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3029683441	GARNET DENTECH Corp	Daegu, KR
3008346537	CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING CO., LTD.	Cangzhou Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013463240. Last updated year: 2026. Please use registration number 3013463240 when referencing this establishment in official correspondence.