Manufacturer registered with FDA

HuangHua DK Dental Co., LTD,

HuangHua, China. Lists 26 dental device types with FDA across 1 registered establishment.

FDA owner/operator10054767Manufacturer
Device types listed
26
Brands and models
27
510(k) clearances
0as applicant
Markets registered in
21 registrations outside the US
Establishments
1China

Registered in 2 markets

Where regulators' registries name HuangHua DK Dental Co., LTD, as the manufacturer or the registration holder of a device.

All markets
United States: 26 device types listedSouth Korea: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerHuangHua DK Dental Co., LTD,26 device types—Below
South KoreaMFDSManufacturerHuangHua DK Dental Co., LTD,12023–2023Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What HuangHua DK Dental Co., LTD, currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Saliva Ejector MouthpieceDYN · Class 1—Maker
Saliva Ejector,Surgical aspirator tip,vented oral Evacuation tip
2017
Dental NeedleDZM · Class 1Dental needles & syringesMaker
Dental needle, Prevent tips
2024
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
Mouth Props,ENDO MEASURE BLOCK,ENDO CLEAN BLOCK;ENDO Ring and ChshionsPoly Wedge;wooden wedge; Silicone Rubber Mixing Tips
2017
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
Mouth Mirrors
2017
Air and/or Water Syringe UnitECB · Class 1Dental hand instrumentsMaker
Air-Water Syringe Tip, Cover Of Air-Water Syringe Tip,Curved Utility Syringes, HP Mixing Tip
2017
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsMaker
Brace elastics
2025
Orthodontic Bracket AlignerECQ · Class 1Dental hand instrumentsMaker
Aligner removal tool
2023
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker
Aligner chewies
2023
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker
Bib Clip; Cotton Roll Clips
2017
Roll CottonEFN · Class 1—Maker
Cotton roll
2024
Manual ToothbrushEFW · Class 1ToothbrushesMaker
Toothbrush
2024
Intraoral Dental WaxEGD · Class 1—Maker
Dental Wax
2024
X-Ray Film HolderEGZ · Class 1—Maker
X-Ray Film Holder, X-Ray system, Ring; Arm, Holder
2017
Preformed Impression TrayEHY · Class 1Impression traysMaker
Tray;Impression Tray; Impression Tray Base; Tray Base;Teeth-whiten tray
2017
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker
Dental tip, Mixing tips
2024
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker
Dental Retractor, Mouth Props
2017
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker
Endo Ruler; Microdont; ENDO MEASURE BLOCK; ENDO CLEAN BLOCK
2017
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker
Probe
2017
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker
Dental sectional contoured matrices; Dental sectional contoured matrices kit
2017
Polishing Agent WheelEJQ · Class 1Polishing & prophylaxisMaker
Polish wheel, strip, brush, cup, dish
2024
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker
Forcep
2017
Oral Hygiene Rubber TipJEW · Class 1Floss & interdental cleanersMaker
Dental tip
2024
Paper Saliva AbsorberKHR · Class 1—Maker
Dental Paper; Dental bib
2024
Resin ApplicatorKXR · Class 1—Maker
Prebent Tips
2025
Accessories Operative Dental UnitNRD · Class 1—Maker
Universal Barrier Film
2017
Dental Implant Surgical TrayOFY · Class 1Implant instruments & surgical kitsMaker
Orthodontic kit
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
HUANGHUA DK DENTAL CO., LTDFDA reg. 3013463240HuangHua Hebei, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10054767). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.