Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000493628

FEI Number

1000493628

Entity Name

IVOCLAR VIVADENT Manufacturing GmbH

City/State/Country

BURS Vorarlberg, AT

Establishment Address

BREMSCHLSTRASSE 16, BURS Vorarlberg A-6706, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

Silamat S6 Gnathometer- CAD Gnathometer-M Bluephase G4 Bluephase G4 100 Bluephase EasyCure Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) Bluephase PowerCure

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2004-01-15
KZO	Ink, Arch Tracing	Dental	Class 1	872.3150	2017-09-28
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2011-09-02
KCR	Facebow	Dental	Class 1	872.3220	2005-07-07
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2019-07-09

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
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02

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3001065024	RENFERT GMBH	HILZINGEN Baden-Wurttemberg, DE
1410097	GC AMERICA INC.	ALSIP, IL, US
9612300	GC CORP.	ITABASHI-KU Tokyo, JP
3035693034	Solventum Germany GmbH	Kist Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000493628. Last updated year: 2026. Please use registration number 1000493628 when referencing this establishment in official correspondence.