Centrix, Inc.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under 2 spellings of the applicant name “Centrix, Inc.” (first 1979, latest 2025), across 20 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 256 days, against 124 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 | 187 |
| 2013 | 0 | — |
| 2014 | 1 | 167 |
| 2015 | 0 | — |
| 2016 | 1 | 241 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 205 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 438 |
| 2024 | 0 | — |
| 2025 | 1 | 256 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Centrix, Inc. took a median 256 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| EMA | Cement, Dental | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 5 | 5 |
| LBH | Varnish, Cavity | 5 | 5 |
| EJK | Liner, Cavity, Calcium Hydroxide | 4 | 4 |
| EKJ | Burnisher, Operative | 4 | 4 |
| MVL | Cord, Retraction | 4 | 4 |
| ELW | Material, Impression | 3 | 3 |
| EID | Syringe, Restorative And Impression Material | 2 | 2 |
| DZN | Instruments, Dental Hand | 1 | 1 |
Plus 10 more product codes.
Review panels
- Dental (48)
Most recent Centrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250714 | FluoroDose Varnish | LBH | 2025-11-21 | 256 |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | PHR | 2023-10-27 | 438 |
| K200764 | STATSTIX | MVL | 2020-10-15 | 205 |
| K152826 | NoCord | ELW | 2016-05-27 | 241 |
| K140144 | BENDA WEDGE | EJB | 2014-07-08 | 167 |
| K120176 | SENZZZZZ AWAY | LBH | 2012-07-25 | 187 |
| K111348 | RE / STASIS (TM) GINGIVAL RETRACTION PASTE | MVL | 2011-07-22 | 70 |
| K092384 | LIQUICORD | MVL | 2009-11-04 | 91 |
| K091380 | CORDCAP | MVL | 2009-07-30 | 80 |
| K021131 | CHLORAPREP | LBH | 2002-09-26 | 171 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Centrix, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Centrix, Inc. (47)
- Centrix Incorporated (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Centrix, Inc.?
FDA lists 48 510(k) clearances under 2 spellings of the applicant name “Centrix, Inc.” (first 1979, latest 2025), across 20 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 Centrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Centrix, Inc. is 85 days. Since 2017: 256 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Centrix, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 5); EMA (Cement, Dental, 5); KLE (Agent, Tooth Bonding, Resin, 5).
Next steps
- See all 48 Centrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Centrix, 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 (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.