Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Implant Protesis Dental 2004, S.L. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
147 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 | 115 | 0 |
| K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2025-08-20 | 99 | 0 |
| K242819 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024-12-19 | 92 | 0 |
| K240570 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024-06-07 | 99 | 0 |
| K231413 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2023-10-10 | 147 | 0 |
| K222215 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2022-10-21 | 88 | 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