Mectron S.P.A.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Mectron S.P.A.” (first 2009, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 3 days, against 178 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 127 |
| 2013 | 1 | 79 |
| 2014 | 1 | 127 |
| 2015 | 2 | 114 |
| 2016 | 1 | 149 |
| 2017 | 0 | — |
| 2018 | 2 | 270 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 3 |
| 2024 | 1 | 3 |
| 2025 | 1 | 1 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mectron S.P.A. took a median 3 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZI | Drill, Bone, Powered | 5 | 5 |
| ELC | Scaler, Ultrasonic | 4 | 4 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
Review panels
- Dental (11)
- Orthopedic (2)
Most recent Mectron S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251425 | turbodent touch | KOJ | 2025-05-09 | 1 |
| K242432 | MT-Bone | DZI | 2024-08-19 | 3 |
| K231391 | Combi Touch | ELC | 2023-05-15 | 3 |
| K171326 | Piezosurgery White | DZI | 2018-04-13 | 343 |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | DZI | 2018-01-12 | 197 |
| K153743 | PIEZOSURGERY PLUS | JDX | 2016-05-25 | 149 |
| K151248 | PIEZOSURGERY WHITE | DZI | 2015-09-04 | 116 |
| K151023 | COMPACT PIEZO LED | ELC | 2015-08-05 | 111 |
| K140965 | MULTIPIEZO PRO, MULTIPIEZO | ELC | 2014-08-20 | 127 |
| K132848 | PIEZOSURGERY FLEX | JDX | 2013-11-29 | 79 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mectron S.P.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mectron S.P.A.?
FDA lists 13 510(k) clearances under the applicant name “Mectron S.P.A.” (first 2009, latest 2025), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mectron S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mectron S.P.A. is 116 days. Since 2017: 3 days, versus 178 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mectron S.P.A.?
The most frequent FDA product codes under this applicant name are DZI (Drill, Bone, Powered, 5); ELC (Scaler, Ultrasonic, 4); JDX (Instrument, Surgical, Sonic And Accessory/Attachment, 2).
Next steps
- See all 13 Mectron S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code DZI, Mectron S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.