FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASONIC SURGERY MACHINE
K Number: K113152
·
Decision Jun 14, 2012
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
48
Applicant Total
5
Review Days
233
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Basic Information
- Device Name
- ULTRASONIC SURGERY MACHINE
- K Number
- K113152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmetec.Co., Ltd.
- Date Received
- October 25, 2011
- Decision Date
- June 14, 2012
- 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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Other Clearances by Dmetec.Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K170104 | COMPACT S, COMPACT S (LED) | Dec 27, 2017 | Substantially Equivalent |
| K121620 | ULTRASONIC SURGERY | Dec 11, 2012 | Substantially Equivalent |
| K060171 | CLEANSE S+ ULTRASONIC SCALER | Mar 29, 2006 | Substantially Equivalent |
| K051571 | SKYLIGHT LED CURING LIGHT | Jul 19, 2005 | Substantially Equivalent |