Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NRQ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
482 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211872 | PiezoImplant System | Rex Implants, Inc. | 2022-10-12 | 482 | 0 |
| K981954 | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | Healthline Implants, Inc. | 1999-01-25 | 235 | 0 |
| K822969 | GENERATION 5 LINKOW BLADE IMPLANTS | Leonard P. Linkow, D.D.L. | 1982-11-04 | 27 | 0 |
| K791366 | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | Oratronics, Inc. | 1979-10-09 | 76 | 0 |
| K791204 | MITER ENDOSTEAL BLADE IMPLANT | Depuy, Inc. | 1979-09-28 | 92 | 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