Nobio , Ltd.: FDA clearances and approvals
Nobio , Ltd. has 5 FDA 510(k) clearances (first 2019, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time: 288 days. Since 2017 its median was 288 days, against 111 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 4 | 290 |
| 2020 | 1 | 119 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Nobio , Ltd.'s cleared 510(k)s took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (5)
Most recent Nobio , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | EBF | 2020-08-14 | 119 |
| K183391 | Novidia Universal Bond | KLE | 2019-09-24 | 291 |
| K182921 | Infinix Universal Composite | EBF | 2019-09-13 | 329 |
| K182714 | Novidia Bulk Fill Flow Composite | EBF | 2019-07-12 | 288 |
| K182580 | Novidia Flowable Composite | EBF | 2019-07-03 | 287 |
Recalls
openFDA lists no recalls under a recalling firm named Nobio , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Nobio , Ltd. have?
Nobio , Ltd. has 5 FDA 510(k) clearances (first 2019, latest 2020), across 2 product codes in 1 review panel.
How long does FDA take to clear Nobio , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Nobio , Ltd.'s cleared 510(k)s is 288 days. Since 2017: 288 days, versus 111 days for all cleared 510(k)s in the same product codes.
What devices does Nobio , Ltd. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 4); KLE (Agent, Tooth Bonding, Resin, 1).
Has Nobio , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Nobio , Ltd. Related entities may recall under other names.
Next steps
- See all 5 Nobio , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Nobio , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.