Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011511773

FEI Number

3011511773

Entity Name

Candulor Dental GmbH

City/State/Country

Rielasingen-Worblingen Baden-Wurttemberg, DE

Establishment Address

Am Riederngraben 6, Rielasingen-Worblingen Baden-Wurttemberg 78239, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

IVOCLAR VIVADENT (Owner Number: 8010208)

Owner / Operator Contact Address

175 Pineview Dr., Amherst, NY 14228, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Articulator CA 3 STRATOS BasePlast Fibers AutoPlast Monomer BasePlast Monomer BasePlast Polymer Aesthetic Intensiv Color AutoPlast AutoPlast Polymer Triplex Cold Triplex Hot Aesthetic Cold Probase High Impact Hot XPLEX Probase Hot Probase Cold Aesthetic Hot Probase High Impact Cold SR Vivoperl Bonartic CT Physioset CT Rim Former New Bite Gauge Bite Plane SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In SR Link Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) PREFERENCE SR Vivodent S PE SR Orthotyp S PE SR Vivodent S DCL SR Orthotyp S DCL SR Ortholingual S DCL PhysioSelect TCR BonSelect TCR Ivotion Dent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJP	Articulators	Dental	Class 1	872.3150	2005-07-07
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2004-10-06
ELL	Teeth, Porcelain	Dental	Class 2	872.3920	2007-11-14
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2019-02-25
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2005-07-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-29
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-11-29
KCR	Facebow	Dental	Class 1	872.3220	2005-07-07
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2010-01-29
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2013-01-08
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2016-05-19

Official Correspondent

Dana Glina

US Agent Details

Anderjeet Gulati Business: Ivoclar Vivadent Email: anderjeet.gulati@ivoclar.com Phone: (716) 2642046

Related Public Records

Same Entity

IVOCLAR VIVADENT

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034244245	DSSM AG	Schaan, LI
3024046877	DSSM GmbH	Lindau Bavaria, DE
3004362235	IVOCLAR VIVADENT, INC.	Diezmo, Cabuyao City Laguna, PH
1316092	IVOCLAR VIVADENT, INC.	AMHERST, NY, US
3003310824	Ivoclar Vivadent Manufacturing GmbH	NATURNO (BZ) Bolzano, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3015131021	SCHOEPF FERTIGUNGSTECHNIK GMBH	Bludesch Vorarlberg, AT
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
1043617	WHIP-MIX CORP.	LOUISVILLE, KY, US
3001297506	DARLEYS SURGICAL CO.	SIALKOT, PUNJAB, PK
3009496224	IVOCLAR VIVADENT, INC.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011511773. Last updated year: 2026. Please use registration number 3011511773 when referencing this establishment in official correspondence.