Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Harvest Dental Products, LLC · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
248 daysmedian FDA review time
282 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC | 2023-08-16 | 96 | 0 |
| K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products, LLC | 2023-06-02 | 248 | 0 |
| K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | 2023-05-12 | 268 | 0 |
| K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | 2018-12-12 | 282 | 0 |
| K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | Harvest Dental Products, LLC | 2014-05-21 | 245 | 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