Mti Precision Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mti Precision Products” (first 1989, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 4 | 4 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
Review panels
- Dental (5)
Most recent Mti Precision Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE | EFB | 2007-02-02 | 30 |
| K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE | EFB | 1996-03-28 | 50 |
| K940261 | LYNX LOW-SPEED HANDPIECE | EFB | 1994-12-29 | 342 |
| K901488 | LYNX-SM, SCLAER DENTAL HANDPIECE | ELC | 1990-05-15 | 47 |
| K895736 | LYNX-HIGH SPEED HANDPIECE | EFB | 1989-12-18 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Mti Precision Products.
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 Mti Precision Products?
FDA lists 5 510(k) clearances under the applicant name “Mti Precision Products” (first 1989, latest 2007), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mti Precision Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mti Precision Products is 50 days.
Which FDA product codes appear under Mti Precision Products?
The most frequent FDA product codes under this applicant name are EFB (Handpiece, Air-Powered, Dental, 4); ELC (Scaler, Ultrasonic, 1).
Next steps
- See all 5 Mti Precision Products clearances with predicates and recalls
- Run predicate analysis for product code EFB, Mti Precision Products'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.