FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Combi Touch
K Number: K231391
·
Decision May 15, 2023
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
13
Review Days
3
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Basic Information
- Device Name
- Combi Touch
- K Number
- K231391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mectron S.P.A.
- Date Received
- May 12, 2023
- Decision Date
- May 15, 2023
- Product Code
- ELC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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 Mectron S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K251425 | turbodent touch | May 9, 2025 | Substantially Equivalent |
| K242432 | MT-Bone | Aug 19, 2024 | Substantially Equivalent |
| K171326 | Piezosurgery White | Apr 13, 2018 | Substantially Equivalent |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Jan 12, 2018 | Substantially Equivalent |
| K153743 | PIEZOSURGERY PLUS | May 25, 2016 | Substantially Equivalent |
| K151248 | PIEZOSURGERY WHITE | Sep 4, 2015 | Substantially Equivalent |
| K151023 | COMPACT PIEZO LED | Aug 5, 2015 | Substantially Equivalent |
| K140965 | MULTIPIEZO PRO, MULTIPIEZO | Aug 20, 2014 | Substantially Equivalent |
| K132848 | PIEZOSURGERY FLEX | Nov 29, 2013 | Substantially Equivalent |
| K122322 | PIEZOSURGERY TOUCH | Dec 6, 2012 | Substantially Equivalent |