Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mycone Dental Supply Co., 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) |
|---|---|---|---|---|---|
| K112597 | SEITY 37% PHOSPHORIC ACID ETCHANT GEL | Mycone Dental Supply Co., Inc. | 2011-12-07 | 91 | 0 |
| K093380 | MIZZY EXPRESS | Mycone Dental Supply Co., Inc. | 2010-03-05 | 127 | 0 |
| K032773 | DIAMOND D HIGH IMPACT DENTURE ACRYLIC | Mycone Dental Supply Co., Inc. | 2003-09-23 | 15 | 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