Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cendres+Metaux SA — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
424 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | 2020-01-15 | 148 | 0 |
| K170102 | Pekkton Ivory | Cendres+Metaux SA | 2017-11-13 | 306 | 0 |
| K130618 | SFI-ANCHOR | Cendres & Metaux SA | 2014-03-03 | 361 | 0 |
| K131526 | SFI-BAR | Cendres & Metaux SA | 2013-09-23 | 118 | 0 |
| K123638 | PEKKTON IVORY | Cendres & Metaux SA | 2013-02-21 | 87 | 0 |
| K111390 | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 | Cendres & Metaux SA | 2011-09-12 | 117 | 0 |
| K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER F | Cendres & Metaux SA | 2010-12-03 | 102 | 0 |
| K083876 | SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT | Cendres & Metaux SA | 2010-02-26 | 424 | 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