Rite-Dent Manufacturing Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Rite-Dent Manufacturing Corp.” (first 2001, latest 2002), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| EMA | Cement, Dental | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
Review panels
- Dental (7)
Most recent Rite-Dent Manufacturing Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020050 | ENAMEL BONDING SYSTEM | KLE | 2002-02-14 | 38 |
| K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | EBC | 2001-08-07 | 57 |
| K011453 | TOOTH SHADE RESIN MATERIAL | EBF | 2001-07-23 | 73 |
| K010255 | CAVITY VARNISH | LBH | 2001-04-20 | 81 |
| K010240 | POLYCARBOXYLATE (PCA) CEMENT | EMA | 2001-03-27 | 61 |
| K003427 | ZINC PHOSPHATE CEMENT | EMA | 2001-01-24 | 82 |
| K003426 | ALGINATE IMPRESSION MATERIAL | ELW | 2001-01-23 | 81 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-09-21.
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 Rite-Dent Manufacturing Corp.?
FDA lists 7 510(k) clearances under the applicant name “Rite-Dent Manufacturing Corp.” (first 2001, latest 2002), across 6 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 Rite-Dent Manufacturing Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rite-Dent Manufacturing Corp. is 73 days.
Which FDA product codes appear under Rite-Dent Manufacturing Corp.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 1); EBF (Material, Tooth Shade, Resin, 1).
Next steps
- See all 7 Rite-Dent Manufacturing Corp. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Rite-Dent Manufacturing Corp.'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.