Cendres & Metaux SA: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cendres & Metaux SA” (first 2010, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 118 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 102 |
| 2014 | 1 | 361 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
Review panels
- Dental (6)
Most recent Cendres & Metaux SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130618 | SFI-ANCHOR | NHA | 2014-03-03 | 361 |
| K131526 | SFI-BAR | NHA | 2013-09-23 | 118 |
| K123638 | PEKKTON IVORY | EBG | 2013-02-21 | 87 |
| K111390 | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. | NHA | 2011-09-12 | 117 |
| K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT | NHA | 2010-12-03 | 102 |
| K083876 | SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT | NHA | 2010-02-26 | 424 |
Recalls
openFDA lists no recalls under a recalling firm named Cendres & Metaux SA.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cendres & Metaux SA?
FDA lists 6 510(k) clearances under the applicant name “Cendres & Metaux SA” (first 2010, latest 2014), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cendres & Metaux SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cendres & Metaux SA is 118 days.
Which FDA product codes appear under Cendres & Metaux SA?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 5); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 6 Cendres & Metaux SA clearances with predicates and recalls
- Run predicate analysis for product code NHA, Cendres & Metaux SA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.