Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Columbus Dental Mfg. Co. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
100 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880754 | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. | 1988-05-12 | 77 | 0 |
| K880607 | UTILITY WAX STRIPS, SPEARMINT | Columbus Dental Mfg. Co. | 1988-03-31 | 48 | 0 |
| K880606 | UTILITY WAX STRIPS, CINNAMON | Columbus Dental Mfg. Co. | 1988-03-24 | 41 | 0 |
| K872243 | PEKALUX(TM) | Columbus Dental Mfg. Co. | 1987-07-07 | 26 | 0 |
| K871164 | GLUMA(TM) BONDING SYSTEM | Columbus Dental Mfg. Co. | 1987-07-02 | 100 | 0 |
| K872272 | PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS | Columbus Dental Mfg. Co. | 1987-07-02 | 20 | 0 |
| K871165 | LUMIFOR(TM) COMPOSITE | Columbus Dental Mfg. Co. | 1987-04-03 | 10 | 0 |
| K863816 | IVORY PREMIUM RUBBER DAM | Columbus Dental Mfg. Co. | 1986-10-27 | 27 | 0 |
| K863758 | ORTHO-BITE WAX WAFER | Columbus Dental Mfg. Co. | 1986-10-07 | 12 | 0 |
| K860855 | SHUR GEL 4 | Columbus Dental Mfg. Co. | 1986-06-16 | 101 | 0 |
| K830083 | SHUR GEL | Columbus Dental Mfg. Co. | 1983-02-07 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda