Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nanova Biomaterials, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
255 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant | Nanova Biomaterials, Inc. | 2018-01-16 | 111 | 0 |
| K171330 | Nanova Sealant | Nanova Biomaterials, Inc. | 2017-09-08 | 126 | 0 |
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | Nanova Biomaterials, Inc. | 2017-05-05 | 129 | 0 |
| K161174 | Nanova Interference Screw | Nanova Biomaterials, Inc. | 2016-11-03 | 191 | 0 |
| K151943 | Vas-Q-Clip | Nanova Biomaterials, Inc. | 2016-03-25 | 255 | 0 |
| K152004 | Nanova Universal Composite | Nanova Biomaterials, Inc. | 2015-11-17 | 120 | 0 |
| K150623 | Nanova Flowable Composite | Nanova Biomaterials, Inc. | 2015-06-18 | 99 | 0 |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | Nanova Biomaterials, Inc. | 2014-09-22 | 215 | 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