FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
turbodent touch
K Number: K251425
·
Decision May 9, 2025
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
13
Review Days
1
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- turbodent touch
- K Number
- K251425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mectron S.P.A.
- Date Received
- May 8, 2025
- Decision Date
- May 9, 2025
- Product Code
- KOJ
- 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 |
|---|---|---|---|
| KOJ | Airbrush | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOJ), ordered by most recent decision date.
BETA-POWDER
FDA 510(k)
FDA Class 2
·Dental
RONDOFLEX PLUS 360
FDA 510(k)
FDA Class 2
·Dental
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
FDA 510(k)
FDA Class 2
·Dental
PREPAIR
FDA 510(k)
FDA Class 2
·Dental
VELOPEX AQUACUT FLUID ABRASION UNIT
FDA 510(k)
FDA Class 2
·Dental
GROMAN PREPMASTER
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Mectron S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K242432 | MT-Bone | Aug 19, 2024 | Substantially Equivalent |
| K231391 | Combi Touch | May 15, 2023 | 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 |