Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Straumann Co. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
368 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041070 | STRAUMANN TEMPORARY COPING | The Straumann Co. | 2004-07-23 | 88 | 0 |
| K040646 | STRAUMANN GRANULES | The Straumann Co. | 2004-05-03 | 53 | 0 |
| K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM | The Straumann Co. | 2004-04-30 | 66 | 0 |
| K993862 | MODUS SAGITTAL SPLIT PLATE | The Straumann Co. | 1999-12-29 | 44 | 0 |
| K962023 | PLASTIC PROTECTION HEALING CAPS | The Straumann Co. | 1996-08-15 | 84 | 0 |
| K960634 | TITANIUM HEALING CAPS | The Straumann Co. | 1996-06-18 | 125 | 1 |
| K955281 | ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES | The Straumann Co. | 1996-03-15 | 120 | 0 |
| K955369 | MEMFIX | The Straumann Co. | 1996-01-23 | 60 | 0 |
| K941393 | ITI ANGLED ABUTMENT | The Straumann Co. | 1995-06-14 | 449 | 0 |
| K943720 | ITI TRANSVERSAL SCREWING SYSTEM | The Straumann Co. | 1995-03-24 | 235 | 0 |
| K931993 | ITI DISTANCE SYSTEM | The Straumann Co. | 1994-04-26 | 368 | 0 |
| K923872 | BONE MARROW BIOPSY SYSTEM | The Straumann Co. | 1992-12-15 | 134 | 0 |
| K920928 | PRE-STERILIZED ITI DENTAL IMPLANTS | The Straumann Co. | 1992-07-15 | 138 | 0 |
| K920768 | HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM | The Straumann Co. | 1992-04-21 | 70 | 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