Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hygienic Dental Mfg., Co., The · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
34 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K780804 | HYGIENIC ANCHORINGS | Hygienic Dental Mfg., Co., The | 1978-06-14 | 34 | 0 |
| K780743 | CLAMP FORCEPS | Hygienic Dental Mfg., Co., The | 1978-05-12 | 29 | 0 |
| K780744 | BRINKER TISSUE RETRACTORS | Hygienic Dental Mfg., Co., The | 1978-05-12 | 29 | 0 |
| K780745 | RUBBER DAM | Hygienic Dental Mfg., Co., The | 1978-05-12 | 29 | 0 |
| K780746 | HYGIENIC RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The | 1978-05-12 | 29 | 0 |
| K770117 | HYGIENIC 5 & 6 RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The | 1977-01-28 | 7 | 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