S.I.N. Sistema DE Implante Nacional S.A.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “S.I.N. Sistema DE Implante Nacional S.A.” (first 2017, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 210 days. Since 2017 the median was 210 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 |
|---|---|---|
| 2017 | 2 | 290 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 140 |
| 2023 | 1 | 86 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name S.I.N. Sistema DE Implante Nacional S.A. took a median 210 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 | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (4)
- General Hospital (1)
Most recent S.I.N. Sistema DE Implante Nacional S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230069 | S.I.N. Dental Implant System | NHA | 2023-04-06 | 86 |
| K221453 | S.I.N. Dental Implant System | DZE | 2022-12-15 | 210 |
| K222514 | S.I.N. Instrument Kits | KCT | 2022-10-27 | 69 |
| K170392 | S.I.N. Implant System | DZE | 2017-12-01 | 296 |
| K170398 | S.I.N. Dental Implant System | DZE | 2017-11-21 | 285 |
Recalls
openFDA lists no recalls under a recalling firm named S.I.N. Sistema DE Implante Nacional S.A..
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 S.I.N. Sistema DE Implante Nacional S.A.?
FDA lists 5 510(k) clearances under the applicant name “S.I.N. Sistema DE Implante Nacional S.A.” (first 2017, latest 2023), 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 S.I.N. Sistema DE Implante Nacional S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name S.I.N. Sistema DE Implante Nacional S.A. is 210 days. Since 2017: 210 days, versus 188 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under S.I.N. Sistema DE Implante Nacional S.A.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 5 S.I.N. Sistema DE Implante Nacional S.A. clearances with predicates and recalls
- Run predicate analysis for product code DZE, S.I.N. Sistema DE Implante Nacional S.A.'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.