Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EHK — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
67 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953628 | PROPHY ANGLE | Rolence Enterprise Co. , Ltd. | 1995-09-29 | 60 | 0 |
| K951016 | DISPOSABLE PROPHYLAXIS ANGLE | Preventive Technologies, Inc. | 1995-05-02 | 57 | 0 |
| K900507 | DISPOSABLE SCREW TYPE PROPHY BRUSH | Dentsply Intl. | 1990-04-10 | 67 | 0 |
| K864059 | DENTAL PROPHY CUPS (VARIOUS TYPES) | Mission White Dental, Inc. | 1986-11-19 | 30 | 0 |
| K803155 | PROPHYLAXIS CUP. | Teledyne Densco | 1981-01-08 | 27 | 0 |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 | 66 | 0 |
| K780198 | PROPHY CUPS, R&R | Ransom and Randolph | 1978-02-16 | 9 | 0 |
| K770556 | PRO-KUP | Dental Control Products | 1977-03-24 | 3 | 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