Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elevate Oral Care — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | 2026-02-27 | 93 | 0 |
| K233768 | Papacarie Duo | Elevate Oral Care | 2024-07-18 | 237 | 0 |
| K150074 | Elevate Moisturizing Spray | Elevate Oral Care | 2015-06-19 | 156 | 0 |
| K131376 | SMARTCOAT 2.5% NAF VARNISH | Elevate Oral Care | 2013-08-27 | 105 | 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