Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Silicon-Und Composite Spezialitaten GmbH · 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) |
|---|---|---|---|---|---|
| K992001 | TRAY-LINK | Silicon-Und Composite Spezialitaten GmbH | 1999-11-02 | 140 | 0 |
| K991450 | ETCHING GEL | Silicon-Und Composite Spezialitaten GmbH | 1999-07-09 | 74 | 0 |
| K960938 | PROV-KB | Silicon-Und Composite Spezialitaten GmbH | 1996-04-18 | 41 | 0 |
| K953476 | MULTI-PRIME AKA/MONO-PRIME | Silicon-Und Composite Spezialitaten GmbH | 1995-09-22 | 60 | 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