Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Formlabs Ohio, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 | 1 | 0 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 | 144 | 0 |
| K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | 2024-02-16 | 218 | 0 |
| K222061 | Dental LT Clear V2 Resin | Formlabs Ohio, Inc. | 2022-11-10 | 120 | 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