Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oral-B Laboratories · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
328 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | Oral-B Laboratories | 1995-04-27 | 300 | 0 |
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | Oral-B Laboratories | 1995-04-27 | 328 | 0 |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Oral-B Laboratories | 1994-09-09 | 70 | 0 |
| K932990 | ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP | Oral-B Laboratories | 1993-09-29 | 103 | 0 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 | 94 | 0 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Oral-B Laboratories | 1993-01-28 | 94 | 0 |
| K913603 | FIBRETWINS | Oral-B Laboratories | 1991-09-30 | 47 | 0 |
| K883024 | ORAL-B FLOSSERS | Oral-B Laboratories | 1988-08-26 | 38 | 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