SOADCO, S.L.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “SOADCO, S.L.” (first 2002, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 165 days. Since 2017 the median was 206 days, against 188 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 296 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 218 |
| 2017 | 1 | 317 |
| 2018 | 1 | 312 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 101 |
| 2024 | 1 | 79 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name SOADCO, S.L. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 5 | 5 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 | 4 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
Review panels
- Dental (9)
- General Hospital (2)
Most recent SOADCO, S.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243128 | Klockner Kits | KCT | 2024-12-18 | 79 |
| K230103 | Klockner Abutments | NHA | 2023-04-24 | 101 |
| K173642 | KLOCKNER SURGICAL BOX | KCT | 2018-10-02 | 312 |
| K170022 | Klockner Vega TiBase for CEREC | NHA | 2017-11-16 | 317 |
| K153098 | KLOCKNER VEGA DENTAL IMPLANT SYSTEM | DZE | 2016-04-08 | 165 |
| K151194 | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) | NHA | 2016-01-29 | 270 |
| K122988 | KLOCKNER DENTAL IMPLANT ABUTMENTS | NHA | 2013-07-19 | 296 |
| K082200 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 | DZE | 2008-11-25 | 113 |
| K080224 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK | DZE | 2008-07-03 | 156 |
| K052654 | KLOCKNER DENTAL IMPLANT, MODEL S3M | DZE | 2006-01-30 | 126 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named SOADCO, S.L..
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 SOADCO, S.L.?
FDA lists 11 510(k) clearances under the applicant name “SOADCO, S.L.” (first 2002, latest 2024), across 3 product codes in 2 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 SOADCO, S.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name SOADCO, S.L. is 165 days. Since 2017: 206 days, versus 188 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under SOADCO, S.L.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5); NHA (Abutment, Implant, Dental, Endosseous, 4); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2).
Next steps
- See all 11 SOADCO, S.L. clearances with predicates and recalls
- Run predicate analysis for product code DZE, SOADCO, S.L.'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.