Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Straumann Manufacturing, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092814 | STRAUMANN DENTAL ABUTMENTS | Straumann Manufacturing, Inc. | 2009-12-15 | 92 | 0 |
| K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS | Straumann Manufacturing, Inc. | 2009-02-26 | 23 | 0 |
| K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE C | Straumann Manufacturing, Inc. | 2008-04-30 | 90 | 0 |
| K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMEN | Straumann Manufacturing, Inc. | 2007-09-20 | 212 | 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