Dentronix, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Dentronix, Inc.” (first 1977, latest 1991), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| FZT | Cutter, Surgical | 5 | 5 |
| HTZ | Instrument, Cutting, Orthopedic | 2 | 2 |
| KMH | Sterilizer, Dry Heat | 2 | 2 |
Review panels
Most recent Dentronix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910202 | DENTRONIX MODEL 2000 | KMH | 1991-03-13 | 62 |
| K880322 | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | KMH | 1988-07-13 | 168 |
| K771006 | MODIFIED PODIATRY PRODUCTS | HTZ | 1977-06-17 | 15 |
| K771005 | NEW PODIATRY PRODUCTS | HTZ | 1977-06-17 | 15 |
| K770305 | CUTTER, P607 BONE | FZT | 1977-03-09 | 21 |
| K770304 | CUTTER, P605 GENERAL PURPOSE | FZT | 1977-03-09 | 21 |
| K770303 | NIPPER, NAIL, P610 ENGLISH | FZT | 1977-03-09 | 21 |
| K770302 | CUTTER, P606 BONE | FZT | 1977-03-09 | 21 |
| K770301 | NIPPER, PSO4 TISSUE | FZT | 1977-03-07 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Dentronix, Inc..
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 Dentronix, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Dentronix, Inc.” (first 1977, latest 1991), across 3 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 Dentronix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentronix, Inc. is 21 days.
Which FDA product codes appear under Dentronix, Inc.?
The most frequent FDA product codes under this applicant name are FZT (Cutter, Surgical, 5); HTZ (Instrument, Cutting, Orthopedic, 2); KMH (Sterilizer, Dry Heat, 2).
Next steps
- See all 9 Dentronix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FZT, Dentronix, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.