Manufacturer registered with FDA
Cendres+Metaux SA
Biel/Bienne, Switzerland. Lists 13 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 13
- Brands and models
- 64
- 510(k) clearances
- 22017–2020
- Markets registered in
- 9432 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Cendres+Metaux SA as the manufacturer or the registration holder of a device.
RegisteredHome: SwitzerlandOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Cendres+Metaux SA | 2 clearances | 2017–2020 | Below |
| Canada | Health Canada | Registration holder | CENDRES+METAUX SA | 323 | 2004–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Cendres+Metaux SACENDRES METAUX SA · CENDRES+ METAUX SA · +2 | 56 | 1998–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Cendres+Métaux SA | 19 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CENDRES + METAUX SACendres+Métaux SA · CENDRES + METAUX · +1 | 14 | 2009–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Cendres + Metaux SA | 9 | 2013–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Cendres+Metaux SA | 6 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CENDRES + MÉTAUX SA | 4 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Cendres+Métaux SA | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Cendres+Metaux SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | TRI Dental Implant SystemTRI-matrix Implant Line | 2010 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CM LOC AbutmentCM LOC Abutment Straumann® RN 4.8 GH1CM LOC Abutment Straumann® RN 4.8 GH2CM LOC Abutment Straumann® RN 4.8 GH3CM LOC Abutment Straumann® RN 4.8 GH4CM LOC Abutment Straumann® RN 4.8 GH5Dalbo AbutmentRC STRAUMANN SFI-ANCHOR ABUTMENTRN STRAUMANN SFI-ANCHOR ABUTMENTTRI Dental Implant System 1 moreTRI-matrix Implant Line | 2010 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | 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®)01060089 Pekkton® ivory Milling blank 98.5/t28mm01060110 Pekkton® ivory Milling blank 95/t12mm 3 more01060131 Pekkton® ivory Milling blank 95/t25mm01060132 Pekkton® ivory Milling blank 95/t30mm01060152 Pekkton® ivory Milling blank 98.5/t12mm | 2017 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Dalbo-ClassicMini-Presso-Matic | 2008 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Livento® pressSoprano®Soprano® 10Soprano® Surface | 2020 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 2008 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | — | 2008 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | — | 2008 |
| Preformed AnchorEJX · Class 1 | — | Maker | CM LOC | 2008 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | — | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | CM LOC AnalogCM LOC Block-out SpacerCM LOC Case guideCM LOC Housing extractorCM LOC Impression partCM LOC Multi-toolCM LOC Parallelometer insertCM LOC Processing InsertCM LOC ScrewdriverCM LOC Spacer 8 moreDalbo-Classic SpacerIpsoclip Centering drillIpsoclip KeyIpsoclip Thread tapIpsoclip Thread tap holderMini-Presso-Matic Auxilliary screw for medellingMini-Presso-Matic ScrewdriverMini-Presso-Matic Thread tap M 2.3x0.25 | 2011 |
| Resin Long-Term Temporary Crown and BridgePOW · Class 2 | — | Maker | 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®)01060089 Pekkton® ivory Milling blank 98.5/t28mm01060110 Pekkton® ivory Milling blank 95/t12mm 3 more01060131 Pekkton® ivory Milling blank 95/t25mm01060132 Pekkton® ivory Milling blank 95/t30mm01060152 Pekkton® ivory Milling blank 98.5/t12mm | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Cendres+Metaux SA lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Cendres & Metaux SA (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Mar 2014 | K130618 | SFI-ANCHOR | Cendres & Metaux SA | NHA Endosseous Dental Implant Abutment |
| 23 Sep 2013 | K131526 | SFI-BAR | Cendres & Metaux SA | NHA Endosseous Dental Implant Abutment |
| 12 Sep 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.. | Cendres & Metaux SA | NHA Endosseous Dental Implant Abutment |
| 3 Dec 2010 | K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT | Cendres & Metaux SA | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CENDRES+METAUX SAFDA reg. 8031058 | Biel/Bienne Bern, Switzerland | Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027574). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.