CANDULOR, AG

FDA Device Registration & Listing · Glattpark Zurich, CH · Registration 1000277456

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000277456
FEI Number
1000277456
Entity Name
CANDULOR, AG
City/State/Country
Glattpark Zurich, CH
Establishment Address
Boulevard Lilienthal 8, Glattpark Zurich CH-8152, CH
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
N
Expiration Date (Year)
2026
510(k) Number
K093331
PMA Number
N/A

All Registered Proprietary Names

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 Articulator CA 3 STRATOS Physiostar NFC Condyloform II NFC SR Modelling Liquid SR Nexco Retention Flow Stains for Resin Teeth finisher SR Nexco SR Nexco Stains SR Nexco Paste SR Nexco Liner SR Nexco Opaquer SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D SR Vivoperl Bonartic CT Physioset CT 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 PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) SR Link SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In PREFERENCE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2004-10-06
EJP Articulators Dental Class 1 872.3150 2005-07-07
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2008-04-17
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-01-29
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2007-11-15
ELL Teeth, Porcelain Dental Class 2 872.3920 2007-11-14
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2016-05-19
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2012-05-22
KCR Facebow Dental Class 1 872.3220 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
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2005-07-07
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2010-01-29

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
3011511773 Candulor Dental GmbH Rielasingen-Worblingen Baden-Wurttemberg, DE
3024046877 DSSM GmbH Lindau Bavaria, DE
3004362235 IVOCLAR VIVADENT, INC. Diezmo, Cabuyao City Laguna, PH
1316092 IVOCLAR VIVADENT, INC. AMHERST, NY, US

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
K070591 Union Dental S.A./Unidesa.Odi REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH 2007-05-11
K915276 Nobelpharma USA, Inc. DENTURE PLASTIC TEETH,76 ELM 1992-02-03
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28

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.).

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Registration Number Establishment Name Location
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2950685 CO-ORAL-ITE DENTAL MFG. CO. DIAMOND SPRINGS, CA, US
3032727 TALON ACRYLICS, INC. Winchester, OR, US
3008320092 Shandong Huge Dental Material Corporation Rizhao Shandong, CN
1410097 GC AMERICA INC. ALSIP, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000277456. Last updated year: 2026. Please use registration number 1000277456 when referencing this establishment in official correspondence.
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