FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ULTRASONIC SCALER
K Number: K140233
·
Decision Apr 6, 2015
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
1
Review Days
431
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Basic Information
- Device Name
- ULTRASONIC SCALER
- K Number
- K140233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanning Baolai Medical Instrument Co., Ltd.
- Date Received
- January 30, 2014
- Decision Date
- April 6, 2015
- Product Code
- ELC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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