Data / Medical devices / Germany / Candulor Dental GmbH

Candulor Dental GmbH: FDA-registered device maker in Rielasingen-Worblingen Baden-Wurttemberg, Germany, 9 510(k) clearances

Name: Candulor Dental GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Candulor Dental GmbH is registered with the FDA (registration 3011511773) in Rielasingen-Worblingen Baden-Wurttemberg, Germany. It lists 9 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 6, 2012. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011511773
Address: Am Riederngraben 6, Rielasingen-Worblingen Baden-Wurttemberg, Germany, 78239
Owner or operator: IVOCLAR VIVADENT (8010208)
Roles: Complaint file establishment, Specification developer
First device listed: January 14, 2004
Registered through: 2027
Brand names listed: Aesthetic Cold, Aesthetic Hot, Aesthetic Intensiv Color, Articulator CA 3, AutoPlast, AutoPlast Monomer, AutoPlast Polymer, BasePlast and more

Devices it lists

Device	Product code	Class	Role	Source
Articulators	EJP	1	Complaint file establishment	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Complaint file establishment	accessdata.fda.gov
Facebow	KCR	1	Complaint file establishment	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	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	Complaint file establishment	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Teeth, Porcelain	ELL	2	Complaint file establishment	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
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
May 19, 2004	K040951	SR ADORO	EBG	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
February 10, 1987	K864707	SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH	ELM	Substantially Equivalent	Ivoclar USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 6, 2012. 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.