Data / Medical devices / Switzerland / Candulor, AG
Candulor, AG: FDA-registered device maker in Glattpark Zurich, Switzerland, 8 510(k) clearances
Candulor, AG is registered with the FDA (registration 1000277456) in Glattpark Zurich, Switzerland. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 24, 2013. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1000277456
- Address
- Boulevard Lilienthal 8, Glattpark Zurich, Switzerland, CH-8152
- Owner or operator
- IVOCLAR VIVADENT (8010208)
- Roles
- Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- January 14, 2004
- Registered through
- 2027
- Brand names listed
- Aesthetic Cold, Aesthetic Hot, Aesthetic Intensiv Color, Aesthetic Wax, Articulator CA 3, AutoPlast, AutoPlast Monomer, AutoPlast Polymer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Articulators | EJP | 1 | Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Foreign private label distributor | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Facebow | KCR | 1 | Complaint file establishment | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Complaint file establishment | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 2 | Complaint file establishment | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
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 24, 2013 | K123304 | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO | EBF | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| December 6, 2012 | K122852 | PHYSIOSTAR NFC | ELM | Substantially Equivalent | Candulor USA, Inc. | accessdata.fda.gov |
| May 14, 2012 | K120736 | SR PHONARES II | ELM | Substantially Equivalent | Ivoclar Vivadent, AG | accessdata.fda.gov |
| January 28, 2010 | K093331 | SR PHONARES NHC | ELM | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| May 8, 2006 | K060565 | CONDYLAFORM II NFC | ELM | Substantially Equivalent | Ivoclar Vivadent, Inc. | accessdata.fda.gov |
| August 6, 1996 | K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | ELM | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| July 22, 1994 | K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | ELL | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| October 17, 1991 | K913655 | PROBASE HOT AND PROBASE COLD | EBI | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Teeth, Porcelain
- All makers of Facebow
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Denture, Plastic, Teeth
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated January 24, 2013. 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.