Cdb Corporation: FDA clearances and approvals
Cdb Corporation has 9 FDA 510(k) clearances (first 1992, latest 2022), across 5 product codes in 1 review panel. Median 510(k) review time: 112 days. Since 2017 its median was 165 days, against 128 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 175 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 165 |
| 2020 | 0 | — |
| 2021 | 1 | 95 |
| 2022 | 1 | 197 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cdb Corporation's cleared 510(k)s took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | 3 | 3 |
| EJF | Bracket, Metal, Orthodontic | 2 | 2 |
| NXC | Aligner, Sequential | 2 | 2 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| PNN | Orthodontic Software | 1 | 1 |
Review panels
- Dental (9)
Most recent Cdb Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212173 | HDH Treatment Planning System | PNN | 2022-01-25 | 197 |
| K210613 | HIT Clear Aligner | NXC | 2021-06-04 | 95 |
| K191823 | Clear-Aligners | NXC | 2019-12-20 | 165 |
| K160957 | CDB Self Ligating Bracket 8F | NJM | 2016-09-27 | 175 |
| K091702 | CDB FLIP-SIDE-CLIP BRACKET | NJM | 2009-08-07 | 58 |
| K080906 | CDB CLIP | NJM | 2008-10-17 | 199 |
| K973776 | REFLECTIONS | DYW | 1997-11-21 | 49 |
| K934881 | REFLECTIONS | EJF | 1994-02-01 | 112 |
| K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF | 1992-07-30 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Cdb Corporation.
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 Cdb Corporation have?
Cdb Corporation has 9 FDA 510(k) clearances (first 1992, latest 2022), across 5 product codes in 1 review panel.
How long does FDA take to clear Cdb Corporation's 510(k)s?
The median time from FDA receipt to decision across Cdb Corporation's cleared 510(k)s is 112 days. Since 2017: 165 days, versus 128 days for all cleared 510(k)s in the same product codes.
What devices does Cdb Corporation make?
Its most frequent FDA product codes are NJM (Bracket, Ceramic, Orthodontic, 3); EJF (Bracket, Metal, Orthodontic, 2); NXC (Aligner, Sequential, 2).
Has Cdb Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Cdb Corporation. Related entities may recall under other names.
Next steps
- See all 9 Cdb Corporation clearances with predicates and recalls
- Run predicate analysis for product code NJM, Cdb Corporation'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.