Impladent , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Impladent , Ltd.” (first 1980, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 190 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 | 1 | 170 |
| 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 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| JEY | Plate, Bone | 1 | 1 |
| NPM | Bone Grafting Material, Animal Source | 1 | 1 |
Review panels
- Dental (10)
Most recent Impladent , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | JEY | 2014-12-18 | 170 |
| K090794 | OSTEOTAPE | NPM | 2009-12-10 | 261 |
| K033098 | OSTEOGEN SBRG | LYC | 2004-04-27 | 211 |
| K982925 | LAMINOSS DENTAL IMPLANT | DZE | 1999-05-18 | 271 |
| K933705 | LAMINOSS DENTAL IMPLANT | DZE | 1996-06-24 | 1060 |
| K923310 | OSTEOGEN (HA RESORB) | LYC | 1995-05-31 | 1058 |
| K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | DZE | 1988-09-01 | 139 |
| K843398 | OSTEOGEN | LYC | 1984-12-27 | 120 |
| K812321 | HYDROXI-FLEX IMPLANT | DZE | 1981-10-29 | 73 |
| K792663 | FLEXI-CUP IMPLANT | DZE | 1980-01-09 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Impladent , Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Impladent, S.L. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Impladent , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Impladent , Ltd.” (first 1980, latest 2014), across 4 product codes 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 Impladent , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Impladent , Ltd. is 190 days.
Which FDA product codes appear under Impladent , Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5); LYC (Bone Grafting Material, Synthetic, 3); JEY (Plate, Bone, 1).
Next steps
- See all 10 Impladent , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Impladent , Ltd.'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.