FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
K Number: K080220
·
Decision Jul 28, 2008
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
1
Review Days
181
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Basic Information
- Device Name
- PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
- K Number
- K080220
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Italia Medica S.R.L.
- Date Received
- January 29, 2008
- Decision Date
- July 28, 2008
- Product Code
- DZI
- 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 |
|---|---|---|---|
| DZI | Drill, Bone, Powered | FDA class 2 | Dental |
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