FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
K Number: K052028
·
Decision Oct 28, 2005
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
14
Review Days
93
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Basic Information
- Device Name
- BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
- K Number
- K052028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bonart Co., Ltd.
- Date Received
- July 27, 2005
- Decision Date
- October 28, 2005
- 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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