Nanova Biomaterials, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Nanova Biomaterials, Inc.” (first 2014, latest 2018), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 128 days. Since 2017 the median was 126 days, against 108 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 215 |
| 2015 | 2 | 110 |
| 2016 | 2 | 223 |
| 2017 | 2 | 128 |
| 2018 | 1 | 111 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nanova Biomaterials, Inc. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
Review panels
- Dental (5)
- Orthopedic (2)
- General and Plastic Surgery (1)
Most recent Nanova Biomaterials, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | KLE | 2018-01-16 | 111 |
| K171330 | Nanova Sealant | EBC | 2017-09-08 | 126 |
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | MAI | 2017-05-05 | 129 |
| K161174 | Nanova Interference Screw | MAI | 2016-11-03 | 191 |
| K151943 | Vas-Q-Clip | FZP | 2016-03-25 | 255 |
| K152004 | Nanova Universal Composite | EBF | 2015-11-17 | 120 |
| K150623 | Nanova Flowable Composite | EBF | 2015-06-18 | 99 |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | LBH | 2014-09-22 | 215 |
Recalls
openFDA lists no recalls under a recalling firm named Nanova Biomaterials, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nanova Biomaterials, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Nanova Biomaterials, Inc.” (first 2014, latest 2018), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nanova Biomaterials, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nanova Biomaterials, Inc. is 128 days. Since 2017: 126 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nanova Biomaterials, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 2); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 8 Nanova Biomaterials, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Nanova Biomaterials, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.