FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
K Number: K061448
·
Decision Aug 17, 2006
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
191
Applicant Total
12
Review Days
87
Basic Information
- Device Name
- BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
- K Number
- K061448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BONART CO. LTD.
- Date Received
- May 22, 2006
- Decision Date
- August 17, 2006
- 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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Other Clearances by BONART CO. LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | Dec 3, 2010 | Substantially Equivalent |
| K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | Nov 13, 2008 | Substantially Equivalent |
| K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | Aug 28, 2008 | Substantially Equivalent |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | Aug 25, 2008 | Substantially Equivalent |
| K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | Oct 26, 2007 | Substantially Equivalent |
| K062289 | BONART ART-L3 LED CURING LIGHT | Jan 3, 2007 | Substantially Equivalent |
| K052028 | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) | Oct 28, 2005 | Substantially Equivalent |
| K023721 | BONART ART-L2 LIGHT CURING UNIT | Jan 10, 2003 | Substantially Equivalent |
| K000510 | ART-M1, MODEL M1-1-ART-A1 | May 15, 2000 | Substantially Equivalent |
| K994203 | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 | Mar 6, 2000 | Substantially Equivalent |