Implant Direct, LLC: FDA clearances and approvals
Implant Direct, LLC has 10 FDA 510(k) clearances (first 2006, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time: 124 days.
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 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
Review panels
- Dental (10)
Most recent Implant Direct, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | DZE | 2009-05-15 | 105 |
| K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM | NHA | 2009-01-14 | 240 |
| K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | NHA | 2009-01-14 | 272 |
| K080633 | SCREWINDIRECT DENTAL IMPLANTS | DZE | 2008-07-15 | 132 |
| K080713 | REACTIVE DENTAL IMPLANT SYSTEM | DZE | 2008-05-16 | 64 |
| K073161 | REPLUS DENTAL IMPLANTS (HA) | DZE | 2008-03-07 | 119 |
| K073049 | SCREWPLUS DENTAL IMPLANTS (HA) | DZE | 2007-12-13 | 45 |
| K073033 | LEGACY DENTAL IMPLANTS | DZE | 2007-12-10 | 45 |
| K061319 | SPECTRA SYSTEM | DZE | 2006-09-29 | 141 |
| K060063 | LEGACY ABUTMENT SYSTEM | NHA | 2006-05-19 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Implant Direct, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Implant Direct, LLC have?
Implant Direct, LLC has 10 FDA 510(k) clearances (first 2006, latest 2009), across 2 product codes in 1 review panel.
How long does FDA take to clear Implant Direct, LLC's 510(k)s?
The median time from FDA receipt to decision across Implant Direct, LLC's cleared 510(k)s is 124 days.
What devices does Implant Direct, LLC make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 7); NHA (Abutment, Implant, Dental, Endosseous, 3).
Has Implant Direct, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Implant Direct, LLC. Related entities may recall under other names.
Next steps
- See all 10 Implant Direct, LLC clearances with predicates and recalls
- Run predicate analysis for product code DZE, Implant Direct, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.