Sb Lucius, Inc.: FDA clearances and approvals
Sb Lucius, Inc. has 15 FDA 510(k) clearances (first 2002, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time: 81 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 15 | 15 |
Review panels
- Dental (15)
Most recent Sb Lucius, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031010 | MIRACLE 98 | EJT | 2003-06-25 | 86 |
| K024143 | AIGIS-FINE | EJT | 2003-03-10 | 84 |
| K024142 | AIGIS-SUPER | EJT | 2003-03-10 | 84 |
| K024136 | AIGIS-SOFT | EJT | 2003-03-10 | 84 |
| K024135 | AIGIS-PLUS | EJT | 2003-03-10 | 84 |
| K024145 | AIGIS-XO | EJT | 2003-03-07 | 81 |
| K024144 | AIGIS-PT | EJT | 2003-03-07 | 81 |
| K024139 | AIGIS-INLAY | EJT | 2003-03-07 | 81 |
| K024141 | NEO 76 | EJT | 2003-03-06 | 80 |
| K024140 | AIGIS-A | EJT | 2003-03-06 | 80 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sb Lucius, Inc..
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 Sb Lucius, Inc. have?
Sb Lucius, Inc. has 15 FDA 510(k) clearances (first 2002, latest 2003), across 1 product code in 1 review panel.
How long does FDA take to clear Sb Lucius, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sb Lucius, Inc.'s cleared 510(k)s is 81 days.
What devices does Sb Lucius, Inc. make?
Its most frequent FDA product codes are EJT (Alloy, Gold-Based Noble Metal, 15).
Has Sb Lucius, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sb Lucius, Inc. Related entities may recall under other names.
Next steps
- See all 15 Sb Lucius, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Sb Lucius, Inc.'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.