Oriola OY Finndent: FDA clearances and approvals
Oriola OY Finndent has 7 FDA 510(k) clearances (first 1989, latest 1990), across 1 product code in 1 review panel. Median 510(k) review time: 76 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 |
|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | 7 | 7 |
Review panels
- Dental (7)
Most recent Oriola OY Finndent 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896602 | FD5000 DENTAL CHAIR | KLC | 1990-02-14 | 85 |
| K893944 | FD 300 DENTAL STOOL | KLC | 1989-08-15 | 76 |
| K893943 | FD 200 DENTAL STOOL | KLC | 1989-08-15 | 76 |
| K893890 | FD4500 (DENTAL CHAIR) | KLC | 1989-08-15 | 77 |
| K893889 | FD3500 (DENTAL CHAIR) | KLC | 1989-08-15 | 77 |
| K893945 | FD 350 DENTAL STOOL | KLC | 1989-08-11 | 72 |
| K893946 | FD 400 DENTAL STOOL | KLC | 1989-08-08 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Oriola OY Finndent.
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 Oriola OY Finndent have?
Oriola OY Finndent has 7 FDA 510(k) clearances (first 1989, latest 1990), across 1 product code in 1 review panel.
How long does FDA take to clear Oriola OY Finndent's 510(k)s?
The median time from FDA receipt to decision across Oriola OY Finndent's cleared 510(k)s is 76 days.
What devices does Oriola OY Finndent make?
Its most frequent FDA product codes are KLC (Chair, Dental, With Operative Unit, 7).
Has Oriola OY Finndent had device recalls?
openFDA lists no recalls under a recalling firm name matching Oriola OY Finndent. Related entities may recall under other names.
Next steps
- See all 7 Oriola OY Finndent clearances with predicates and recalls
- Run predicate analysis for product code KLC, Oriola OY Finndent'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.