Columbus Dental Mfg. Co.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Columbus Dental Mfg. Co.” (first 1983, latest 1988), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| EGD | Wax, Dental, Intraoral | 3 | 3 |
| ELW | Material, Impression | 2 | 2 |
| EHZ | Evacuator, Oral Cavity | 1 | 1 |
| EIE | Dam, Rubber | 1 | 1 |
Review panels
- Dental (11)
Most recent Columbus Dental Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880754 | DRI-CLAVE LIQUID KLEENZALL | EHZ | 1988-05-12 | 77 |
| K880607 | UTILITY WAX STRIPS, SPEARMINT | EGD | 1988-03-31 | 48 |
| K880606 | UTILITY WAX STRIPS, CINNAMON | EGD | 1988-03-24 | 41 |
| K872243 | PEKALUX(TM) | EBF | 1987-07-07 | 26 |
| K872272 | PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS | EBF | 1987-07-02 | 20 |
| K871164 | GLUMA(TM) BONDING SYSTEM | EBF | 1987-07-02 | 100 |
| K871165 | LUMIFOR(TM) COMPOSITE | EBF | 1987-04-03 | 10 |
| K863816 | IVORY PREMIUM RUBBER DAM | EIE | 1986-10-27 | 27 |
| K863758 | ORTHO-BITE WAX WAFER | EGD | 1986-10-07 | 12 |
| K860855 | SHUR GEL 4 | ELW | 1986-06-16 | 101 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Columbus Dental Mfg. Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Columbus Instruments Intl. Corp. (5 510(k)s)
- Columbus Mckinnon Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Columbus Dental Mfg. Co.?
FDA lists 11 510(k) clearances under the applicant name “Columbus Dental Mfg. Co.” (first 1983, latest 1988), across 5 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 Columbus Dental Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Columbus Dental Mfg. Co. is 27 days.
Which FDA product codes appear under Columbus Dental Mfg. Co.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 4); EGD (Wax, Dental, Intraoral, 3); ELW (Material, Impression, 2).
Next steps
- See all 11 Columbus Dental Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Columbus Dental Mfg. Co.'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.