Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sunstar Americas, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral | Sunstar Americas, Inc. | 2018-07-13 | 74 | 0 |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | 2013-10-29 | 95 | 0 |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | Sunstar Americas, Inc. | 2011-02-03 | 196 | 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