Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hoyt Laboratories · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
16 daysmedian FDA review time
22 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820738 | LUSTRALLOY | Hoyt Laboratories | 1982-04-09 | 22 | 0 |
| K811154 | HOYT ECONO-TRAY | Hoyt Laboratories | 1981-05-13 | 15 | 0 |
| K810830 | HOYT COTTON ROLLS | Hoyt Laboratories | 1981-04-14 | 20 | 0 |
| K780834 | PREVI DENT PROPHYLAXIS MINT NDC | Hoyt Laboratories | 1978-06-02 | 9 | 0 |
| K771881 | REPLICA BONDING AGENT | Hoyt Laboratories | 1977-11-09 | 36 | 0 |
| K771880 | REPLICA DENTAL COMPOSIT | Hoyt Laboratories | 1977-10-20 | 16 | 0 |
| K771882 | REPLICA DENTAL COMPOSITE-RADIOPAQUE | Hoyt Laboratories | 1977-10-20 | 16 | 0 |
| K771883 | REPLICA ACID-ETCH | Hoyt Laboratories | 1977-10-20 | 16 | 0 |
| K771183 | TOOTHBRUSH, PEDODONTIC, #0126-0188-00 | Hoyt Laboratories | 1977-07-15 | 16 | 0 |
| K771185 | PERIODONTIC TOOTHBRUSH, #0126-0190-00 | Hoyt Laboratories | 1977-07-15 | 16 | 0 |
| K771184 | TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 | Hoyt Laboratories | 1977-07-15 | 16 | 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