Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Mectron S.P.A. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
197 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251425 | turbodent touch | Mectron S.P.A. | 2025-05-09 | 1 | 0 |
| K242432 | MT-Bone | Mectron S.P.A. | 2024-08-19 | 3 | 0 |
| K231391 | Combi Touch | Mectron S.P.A. | 2023-05-15 | 3 | 0 |
| K171326 | Piezosurgery White | Mectron S.P.A. | 2018-04-13 | 343 | 0 |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | 2018-01-12 | 197 | 0 |
| K153743 | PIEZOSURGERY PLUS | Mectron S.P.A. | 2016-05-25 | 149 | 0 |
| K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | 2015-09-04 | 116 | 0 |
| K151023 | COMPACT PIEZO LED | Mectron S.P.A. | 2015-08-05 | 111 | 0 |
| K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | 2014-08-20 | 127 | 0 |
| K132848 | PIEZOSURGERY FLEX | Mectron S.P.A. | 2013-11-29 | 79 | 0 |
| K122322 | PIEZOSURGERY TOUCH | Mectron S.P.A. | 2012-12-06 | 127 | 0 |
| K102218 | COMPACT PIEZO P2K, POWERCARE | Mectron S.P.A. | 2011-01-24 | 171 | 0 |
| K092951 | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS | Mectron S.P.A. | 2009-12-07 | 74 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda