Manufacturer registered with FDA
Huanghua Promisee Dental Co., Ltd
Huanghua, China. Lists 40 dental device types with FDA across 1 registered establishment.
- Device types listed
- 40
- Brands and models
- 85
- 510(k) clearances
- 0as applicant
- Markets registered in
- 11348 registrations outside the US
- Establishments
- 1China
Registered in 11 markets
Where regulators' registries name Huanghua Promisee Dental Co., Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Huanghua Promisee Dental Co., Ltd | 40 device types | — | Below |
| South Korea | MFDS | Manufacturer | Huanghua Promisee Dental Co., LtdHuanghua Promisee Dental Co.,LTD. · Huanghua Promisee Dental Co.,Ltd · +2 | 76 | 2010–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Huanghua Promisee Dental Co.Ltd. | 72 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HUANGHUA PROMISEE DENTAL CO., LTDHUANGHUA PROMISEE DENTAL CO LTD | 45 | 2010–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Huanghua Promisee Dental Co Ltd | 39 | 2015–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HUANGHUA PROMISEE DENTAL CO., LTDHUANGHUA PROMISEE DENTAL CO. LTD · HUANGHUA PROMISEE DENTAL CO.,LTD | 32 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Huanghua Promisee Dental Co Ltd | 31 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HUANGHUA PROMISEE DENTAL CO., LTD.HUANGHUA PROMISEE DENTAL CO., LTD · Huanghua Promisee Dental Co., ltd · +1 | 26 | 2017–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Huanghua Promisee Dental Co., Ltd. | 16 | 2023–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HUANGHUA PROMISEE DENTAL CO., LTD. | 8 | 2022–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | HUANGHUA PROMISEE DENTAL CO., LTDHuanghua Promisee Dental Co., Ltd · Huanghua Promisee Dental Co., Ltd. | 3 | — | Pure 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 Promisee Dental Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Dry Field SystemTubingEndodontic Aspirator TipSaliva ejectorSmart Saliva Ejectors | 2011 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | aligner chewies | 2023 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental WedgeSmart Dental Wedges | 2011 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | disposable mirrors | 2011 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air water dental syringe tipdental syringe cleanser | 2011 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | clamping ringcotton roll clipdental bib clip | 2023 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | aligner removal | 2023 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Aligner Chewies, Retainer Retrievers, Invisible Braces Box | 2024 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | Dental Dam KitWedge Floss | 2022 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Bib clipcotton roll clips | 2015 |
| Roll CottonEFN · Class 1 | — | Maker | cotton ballcotton roll | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush | 2023 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Base Plate Waxoccusal rim/wax rim | 2017 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | X-ray film holder | 2011 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Polishing Discs | 2022 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy brushProphy cup | 2019 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Composite Polisher | 2023 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Prophy strip | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | ADJUSTABLE IMPRESSION TRAYAutoclavable IMPRESSION trayDisposable IMPRESSION traygeneral trayIMPLANT TRAYImpression tray baseTEETH WHITEING TRAYtray base | 2011 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator, Oral Cavity | 2014 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | DENTAL SYRINGE | 2023 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | compule dispenser gun | 2023 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Punch | 2022 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Dental retractor | 2011 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | mouth propRETRACTORrubber dam retractor | 2023 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Dental RulerEndo rulerMeasuring GuageMicrodontroot cannal measuring ruler | 2015 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Probe | 2013 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Adhesive tip applicatorAdhesive Tip ApplicatorsMatrix Bands KitOne piece of medical forcepsPerfect Cheek Retractorswedgeguards20 pieces of clearance wedges with holes in four types20 pieces of resin matrix bands in both large and small size20 pieces of software clearance wedges in four types20 pieces of subgingival matrix bands in large size 7 more20 pieces of subgingival matrix bands in medium size20pieces of subgingival matrix bands in small size50 pieces of ordinary matrix bands in medium size50 pieces of ordinary matrix bands in small size50pieces of ordinary matrix bands in large size6 pieces of clamping rings6 pieces of silicon clearance wedges | 2015 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | Frame | 2022 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | Clamp | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophy Paste | 2023 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Dental Sectional Contoured Matrices Kits, Matrix Bands | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Point | 2023 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | forcep | 2013 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental Bibs | 2021 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Disposable Fluoride Tray | 2014 |
| Resin ApplicatorKXR · Class 1 | — | Maker | micro applicatorPerfect Gingival Brushes | 2015 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Guide Syestem Kit | 2021 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Universal barrier film | 2011 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | 3 in 1 disposable dental kit5 in 1 disposable dental kit7 in 1 disposable dental kit8 in 1 disposable dental kit | 2013 |
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
| Establishment | Location | What it does |
|---|---|---|
| HUANGHUA PROMISEE DENTAL CO., LTDFDA reg. 3009420946 | Huanghua Hebei, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10038868). 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.