Data / Medical devices / Switzerland / Cendres+metaux SA
Cendres+metaux SA: FDA-registered device maker in Biel/Bienne Bern, Switzerland, 6 510(k) clearances
Cendres+metaux SA is registered with the FDA (registration 8031058) in Biel/Bienne Bern, Switzerland. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 15, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8031058
- FEI number
- 3002806651
- Address
- Rue de Boujean 122, Biel/Bienne Bern, Switzerland, CH-2501
- Owner or operator
- CENDRES+METAUX SA (10027574)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 18, 2008
- Registered through
- 2026
- Brand names listed
- 01060003 Pekkton® ivory press blanks / 10 p., 01060011 Pekkton® ivory milling blank ø 98.5/16mm (with steps), 01060014 Pekkton® ivory milling blank ø 98.5/t12mm (with steps), 01060020 Pekkton® ivory milling blank ø 98.5/20mm (with steps), 01060022 Pekkton® ivory milling blank ø 98.5/24mm (with steps), 01060028 Pekkton® ivory milling blank ø 95/16mm (compatible with Zirkonzahn®), 01060030 Pekkton® ivory milling blank ø 95/20mm (compatible with Zirkonzahn®), 01060032 Pekkton® ivory milling blank ø 95/24mm (compatible with Zirkonzahn®) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 15, 2020 | K192251 | Livento Press, Soprano 10, Soprano | EIH | Substantially Equivalent | Cendres+Metaux SA | accessdata.fda.gov |
| November 13, 2017 | K170102 | Pekkton Ivory | EBF | Substantially Equivalent | Cendres+Metaux SA | accessdata.fda.gov |
| March 3, 2014 | K130618 | SFI-ANCHOR | NHA | Substantially Equivalent | Cendres & Metaux SA | accessdata.fda.gov |
| September 23, 2013 | K131526 | SFI-BAR | NHA | Substantially Equivalent | Cendres & Metaux SA | accessdata.fda.gov |
| September 12, 2011 | 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 | Substantially Equivalent | Cendres & Metaux SA | accessdata.fda.gov |
| December 3, 2010 | K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT | NHA | Substantially Equivalent | Cendres & Metaux SA | accessdata.fda.gov |
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Updated January 15, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.