Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EIL · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
103 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911643 | ABIODENT PERIOTEMP(R) SYSTEM | Abiomed, Inc. | 1991-07-09 | 88 | 0 |
| K890493 | FLORIDA PROBE PERIODONTAL PROBE | Florida Probe Corp. | 1989-03-13 | 41 | 0 |
| K885075 | ABIOMED PERIOTEMP(TM) PROBE | Abiomed, Inc. | 1989-02-13 | 67 | 0 |
| K884813 | MODEL 200A ELECTRONIC FORCE-SENSING PROBE | Vine Valley Research | 1989-01-05 | 49 | 0 |
| K880209 | PERIODONTAL PROBE - AUTOPROBE | Dentsply Intl. | 1988-04-27 | 103 | 0 |
| K872098 | CREMEEN ALVEOLAR BONE CALIPER | Bowen & Company, Inc. | 1987-07-31 | 60 | 0 |
| K872215 | PERIO-TEST | Dr. Bernard Loewenthal | 1987-07-10 | 31 | 0 |
| K822793 | PIO ROOT CANAL INDICATOR | National Patent Development Corp. | 1982-10-22 | 36 | 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