Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oriola OY Finndent · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
85 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896602 | FD5000 DENTAL CHAIR | Oriola OY Finndent | 1990-02-14 | 85 | 0 |
| K893944 | FD 300 DENTAL STOOL | Oriola OY Finndent | 1989-08-15 | 76 | 0 |
| K893890 | FD4500 (DENTAL CHAIR) | Oriola OY Finndent | 1989-08-15 | 77 | 0 |
| K893889 | FD3500 (DENTAL CHAIR) | Oriola OY Finndent | 1989-08-15 | 77 | 0 |
| K893943 | FD 200 DENTAL STOOL | Oriola OY Finndent | 1989-08-15 | 76 | 0 |
| K893945 | FD 350 DENTAL STOOL | Oriola OY Finndent | 1989-08-11 | 72 | 0 |
| K893946 | FD 400 DENTAL STOOL | Oriola OY Finndent | 1989-08-08 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda