Impla-Med: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Impla-Med” (first 1989, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time under this name: 114 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 | 5 | 5 |
Review panels
- Dental (5)
Most recent Impla-Med 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | DZE | 1992-10-27 | 193 |
| K902911 | TITANIUM/STAINLESS STEEL INSTRUMENTS | DZE | 1990-09-06 | 66 |
| K902158 | TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP | DZE | 1990-08-09 | 86 |
| K900061 | IMPLA-MED TITANIUM, IMPLANT DEVICES | DZE | 1990-04-27 | 114 |
| K892124 | IMPLA-MED IMPLANT SYSTEM | DZE | 1989-10-20 | 199 |
Recalls
openFDA lists no recalls under a recalling firm named Impla-Med.
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 Impla-Med?
FDA lists 5 510(k) clearances under the applicant name “Impla-Med” (first 1989, latest 1992), 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 Impla-Med?
The median time from FDA receipt to decision across 510(k)s cleared under the name Impla-Med is 114 days.
Which FDA product codes appear under Impla-Med?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5).
Next steps
- See all 5 Impla-Med clearances with predicates and recalls
- Run predicate analysis for product code DZE, Impla-Med'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.