Description
Device Description
A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line.
The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.
Indications for Use
THE MODEL 3003 SCALER is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.
Product Information
Model Name: THE MODEL 3003 SCALER
Power Supply
Input Voltage: 3.7VDC 50HZ
Output Power: 2.8W
Operating Conditions
Temperature: 0-35°C
Relative Humidity: <80%R.H
Pressure: 70-106kpa
Storage Conditions
Temperature: 0°C - +40°C
Relative Humidity: <80%R.H
Pressure: 70-106kpa
510(k) Number: K930698
Device Name: THE MODEL 3003 SCALER
Manufacturer: HENGSHENG INDUSTRY CO., LIMITED
| Device Name: | THE MODEL 3003 SCALER |
| Classification Name: | SCALER, ULTRASONIC |
| Product Code: | ELC |
| Device Class: | 2 |
| Regulation Number: | 872.4850 |
| Medical Specialty: | Dental |
| Registered Establishment Name: | HENGSHENG INDUSTRY CO., LIMITED |
| Registered Establishment Number: | 3031700049 |
| Premarket Submission Number: | K930698 |
| Owner/Operator: | HENGSHENG INDUSTRY CO., LIMITED |
| Owner/Operator Number: | 10091155 |
| Establishment Operations: | Manufacturer; Remanufacturer; Repackager/Relabeler |