Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
St. George Technology, Inc. · 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) |
|---|---|---|---|---|---|
| K023953 | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY | St. George Technology, Inc. | 2003-02-14 | 79 | 0 |
| K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | St. George Technology, Inc. | 2000-02-10 | 227 | 0 |
| K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE | St. George Technology, Inc. | 1995-02-02 | 73 | 0 |
| K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO | St. George Technology, Inc. | 1994-01-18 | 154 | 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