Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
S.I.N. - Sistema DE Implante Nacional S.A. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
285 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240609 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-17 | 135 | 0 |
| K241378 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-07-12 | 58 | 0 |
| K232821 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2024-05-31 | 261 | 0 |
| K231127 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2023-12-07 | 231 | 0 |
| K230069 | S.I.N. Dental Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2023-04-06 | 86 | 0 |
| K221453 | S.I.N. Dental Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2022-12-15 | 210 | 0 |
| K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-10-27 | 94 | 1 |
| K222514 | S.I.N. Instrument Kits | S.I.N. – Sistema DE Implante Nacional S.A. | 2022-10-27 | 69 | 0 |
| K222005 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-09-29 | 84 | 0 |
| K212404 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-11-03 | 93 | 0 |
| K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-10-20 | 121 | 0 |
| K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021-06-23 | 184 | 0 |
| K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-11-17 | 216 | 0 |
| K201688 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-10-21 | 121 | 0 |
| K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-05-14 | 189 | 0 |
| K170392 | S.I.N. Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2017-12-01 | 296 | 0 |
| K170398 | S.I.N. Dental Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2017-11-21 | 285 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda