Elos Medtech Pinol A/S: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Elos Medtech Pinol A/S” (first 2018, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 175 days. Since 2017 the median was 175 days, against 165 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 213 |
| 2019 | 1 | 135 |
| 2020 | 3 | 206 |
| 2021 | 1 | 228 |
| 2022 | 1 | 142 |
| 2023 | 2 | 218 |
| 2024 | 2 | 122 |
| 2025 | 1 | 154 |
| 2026 | 1 | 175 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Elos Medtech Pinol A/S took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 13 | 13 |
Review panels
- Dental (13)
Most recent Elos Medtech Pinol A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253774 | Elos Accurate® Denture Fixation System | NHA | 2026-05-20 | 175 |
| K251497 | Elos Accurate Hybrid Base | NHA | 2025-10-16 | 154 |
| K242025 | Elos Accurate® Hybrid Base | NHA | 2024-12-10 | 152 |
| K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | NHA | 2024-09-13 | 91 |
| K231307 | Elos Accurate Customized Abutment | NHA | 2023-12-21 | 230 |
| K230317 | Elos Accurate Hybrid Base | NHA | 2023-09-01 | 207 |
| K222044 | Elos Accurate Customized Abutment | NHA | 2022-11-30 | 142 |
| K201860 | Elos Accurate Hybrid Base | NHA | 2021-02-19 | 228 |
| K191919 | Elos Accurate Hybrid Base | NHA | 2020-02-10 | 207 |
| K191890 | Elos Accurate Customized Abutment | NHA | 2020-02-06 | 206 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elos Medtech Pinol A/S.
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 Elos Medtech Pinol A/S?
FDA lists 13 510(k) clearances under the applicant name “Elos Medtech Pinol A/S” (first 2018, latest 2026), 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 Elos Medtech Pinol A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elos Medtech Pinol A/S is 175 days. Since 2017: 175 days, versus 165 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elos Medtech Pinol A/S?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 13).
Next steps
- See all 13 Elos Medtech Pinol A/S clearances with predicates and recalls
- Run predicate analysis for product code NHA, Elos Medtech Pinol A/S'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.