Yongqing Huaguan Dental Instruments Factory
Registered establishment in Langfang, Hebei, China. 9 device types, 1 clearance.
Yongqing Huaguan Dental Instruments Factory is a contract manufacturer holding a current FDA establishment registration. The registration covers Cup, Prophylaxis, Evacuator, Oral Cavity and 7 other device types. Its earliest product listing with the FDA dates from 2018.
9device types registered with the FDA
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3014345250 |
| FEI number | 3014345250 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Langfang |
|---|---|
| Province | Hebei |
| Address | Intersection of Ronghua Road and Siwei Street |
| Postal code | 065600 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Poly Towels, Patient Bibs, Poly Bibs | 2019 | 86 |
| Chair, Dental, Without Operative Unit | Class 1 | Barrier Films, Plastic Covers, Plastic Bags | 2018 | 38 |
| Cup, Prophylaxis | Class 1 | dental mixing well | 2022 | 49 |
| Dental Barriers And Sleeves | Class 2 | Dental Barrier and Sleeves | 2024 | 12 |
| Evacuator, Oral Cavity | Class 1 | Evacuator, Oral Cavity | 2021 | 49 |
| Mouthpiece, Saliva Ejector | Class 1 | Mouthpiece, Saliva Ejector | 2021 | 68 |
| Tray, Impression, Preformed | Class 1 | Tray, impression ,Preformed | 2021 | 73 |
| Unit, Operative Dental, Accessories | Class 1 | Plastic Covers, Barrier Films, Plastic Bags | 2019 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | Air/Water Syringe Tips | 2018 | 56 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233918 | 2024-05-09 | PEM | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Beijing Jinwei Kangda Medical Instrument Ltd. | 21 |
| Yueying Medical Instruments (Langfang) Co., Ltd. | 9 |
| CAO (China) Medical Equipment Company, Limited | 6 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | 5 |
| Dacheng Huaguan Dental Instruments Co., Ltd. | 4 |
| Sanhe Lefis Electronics Co., Ltd. | 2 |
| Sanhe Laserconn Tech Co., Ltd. | 2 |
| Gu’an Yeolight Smart Electronics Co., Ltd. | 1 |
| Green Source Technology (Hebei) Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.