Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imcor · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
104 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992512 | ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, A | Imcor | 1999-11-01 | 97 | 0 |
| K983563 | IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4. | Imcor | 1999-01-11 | 90 | 0 |
| K982492 | IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES | Imcor | 1998-10-15 | 90 | 0 |
| K974126 | IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COAT | Imcor | 1998-01-30 | 88 | 0 |
| K973049 | IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL | Imcor | 1997-11-13 | 90 | 0 |
| K960899 | IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW | Imcor | 1996-06-17 | 104 | 0 |
| K960900 | IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW | Imcor | 1996-06-05 | 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