Data / Medical devices / China / Yongqing Huaguan Dental Instruments Factory
Yongqing Huaguan Dental Instruments Factory: FDA-registered device maker in Langfang City Hebei, China, 1 510(k) clearance
Yongqing Huaguan Dental Instruments Factory is registered with the FDA (registration 3014345250) in Langfang City Hebei, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014345250
- Address
- Intersection of Ronghua Road and Siwei Street Yongqing Industrial Area, Langfang City Hebei, China, 065600
- Owner or operator
- Yongqing Huaguan Dental Instruments Factory (10057201)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 6, 2018
- Registered through
- 2026
- Brand names listed
- Air/Water Syringe Tips, Barrier Films, Barrier Films, Plastic Covers, Plastic Bags, Dental Barrier and Sleeves, Evacuator, Oral Cavity, Mouthpiece, Saliva Ejector, Patient Bibs, Plastic Bags and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 9, 2024 | K233918 | Dental Barrier and Sleeves | PEM | Substantially Equivalent | Yongqing Huaguan Dental Instruments Factory | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Dental, Without Operative Unit
- All makers of Tray, Impression, Preformed
- All makers of Unit, Operative Dental, Accessories
- All makers of Evacuator, Oral Cavity
- All makers of Absorber, Saliva, Paper
- All makers of Dental Barriers And Sleeves
Updated May 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.