S.I.N. - Sistema DE Implante Nacional S.A.: FDA clearances and approvals
S.I.N. - Sistema DE Implante Nacional S.A. has 12 FDA 510(k) clearances (first 2020, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time: 128 days. Since 2017 its median was 128 days, against 210 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 3 | 189 |
| 2021 | 3 | 121 |
| 2022 | 2 | 89 |
| 2023 | 1 | 231 |
| 2024 | 3 | 135 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, S.I.N. - Sistema DE Implante Nacional S.A.'s cleared 510(k)s took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 8 | 8 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 | 4 |
Review panels
- Dental (8)
- General Hospital (4)
Most recent S.I.N. - Sistema DE Implante Nacional S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240609 | S.I.N. Dental Implant System | DZE | 2024-07-17 | 135 |
| K241378 | S.I.N. Instrument Kits | KCT | 2024-07-12 | 58 |
| K232821 | S.I.N. Dental Implant System | DZE | 2024-05-31 | 261 |
| K231127 | S.I.N. Dental Implant System | DZE | 2023-12-07 | 231 |
| K222231 | S.I.N. Dental Implant System | DZE | 2022-10-27 | 94 |
| K222005 | S.I.N. Instrument Kits | KCT | 2022-09-29 | 84 |
| K212404 | S.I.N. Instrument Kits | KCT | 2021-11-03 | 93 |
| K211921 | S.I.N. Dental Implant System | DZE | 2021-10-20 | 121 |
| K203725 | S.I.N. Dental Implant System | DZE | 2021-06-23 | 184 |
| K200992 | S.I.N. Dental Implant System | DZE | 2020-11-17 | 216 |
2 earlier clearances. See the full list in Caduvo.
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 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 S.I.N. - Sistema DE Implante Nacional S.A. have?
S.I.N. - Sistema DE Implante Nacional S.A. has 12 FDA 510(k) clearances (first 2020, latest 2024), across 2 product codes in 2 review panels.
How long does FDA take to clear S.I.N. - Sistema DE Implante Nacional S.A.'s 510(k)s?
The median time from FDA receipt to decision across S.I.N. - Sistema DE Implante Nacional S.A.'s cleared 510(k)s is 128 days. Since 2017: 128 days, versus 210 days for all cleared 510(k)s in the same product codes.
What devices does S.I.N. - Sistema DE Implante Nacional S.A. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 8); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 4).
Has S.I.N. - Sistema DE Implante Nacional S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching S.I.N. - Sistema DE Implante Nacional S.A. Related entities may recall under other names.
Next steps
- See all 12 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.