Imcor: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Imcor” (first 1996, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
Review panels
- Dental (7)
Most recent Imcor 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992512 | ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA | DZE | 1999-11-01 | 97 |
| K983563 | IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I | DZE | 1999-01-11 | 90 |
| K982492 | IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES | DZE | 1998-10-15 | 90 |
| K974126 | IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW | DZE | 1998-01-30 | 88 |
| K973049 | IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM | DZE | 1997-11-13 | 90 |
| K960899 | IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW | DZE | 1996-06-17 | 104 |
| K960900 | IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW | DZE | 1996-06-05 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Imcor.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Imcor?
FDA lists 7 510(k) clearances under the applicant name “Imcor” (first 1996, latest 1999), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imcor?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imcor is 90 days.
Which FDA product codes appear under Imcor?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 7).
Next steps
- See all 7 Imcor clearances with predicates and recalls
- Run predicate analysis for product code DZE, Imcor's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.