Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ed. Geistlich Soehne AG Fuer Chemische Industrie · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
543 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092428 | BIO-OSS COLLAGEN | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2010-03-18 | 223 | 0 |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008-05-30 | 151 | 0 |
| K061244 | MUCOGRAFT | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006-06-06 | 34 | 0 |
| K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND B | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005-08-09 | 168 | 0 |
| K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND B | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004-11-15 | 94 | 0 |
| K012423 | MUCOGRAFT | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2003-01-24 | 543 | 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