FDA Registration
Active
🇮🇹 Italy
Ivoclar Vivadent Manufacturing GmbH
Reg #: 3003310824
·
FEI: 3003310824
·
Expires 2026
Products
10
Proprietary Names
118
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Ivoclar Vivadent Manufacturing GmbH
- Registration Number
- 3003310824
- FEI Number
- 3003310824
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Gustav Flora 32
- City
- NATURNO (BZ) Bolzano
- Country
- IT
Owner / Operator
- Firm Name
- IVOCLAR VIVADENT
- Operator Number
- 8010208
- Address
- 175 Pineview Dr.
- City
- Amherst
- State
- NY
- Postal Code
- 14228
- Country
- US
- Correspondent
- Dana Glina
US Agent
- Business Name
- Ivoclar Vivadent
- Contact Name
- Anderjeet Gulati
- Address
- 175 Pineview Dr.
- City
- Amherst
- State
- NY
- ZIP
- 14228
- Country
- US
- [email protected]
- Phone
- 716 2642046
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2010-03-16 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2004-01-14 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-05-24 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2012-05-24 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-11-05 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2005-07-07 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2007-11-14 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2019-09-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2003-06-26 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2006-10-20 |
Proprietary Names
TelioCAD for M-Center
TelioCAD for Milling Center
Telio CAD for PlanMill
Telio CAD for Cerec
Telio CAD LT discs
Telio CAD disc
Telio CAD
SR ORTHOLINGUAL DCL
SR VIVODENT DCL
SR Orthotyp DCL
Candulor brand denture teeth
Candulor Physioset TCR
Candulor Bonartic TCR
BlueLine
SR ORTHOPLANE DCL
IPS Style Ceram
IPS Style Ceram One
IPS Build-Up Liquid
IPS Style Ceram Transpa
IPS e.max CAD for Planmill
IPS e.max CAD MT
IPS e.max CAD LT
IPS e.max ZirCAD for Inlab
IPS e.max CAD Impulse
IPS e.max CAD HT
IPS e.max CAD for InLab
IPS e.max ZirCAD for PlanMill
IPS e.max CAD CEREC
IPS e.max CAD
IPS e.max ZirCAD
CAD/CAM CEREC Starter Kit
CAD/CAM PlanMill Starter Kit
IvoBase Hybrid
IvoBase High Impact
SR Ivocap High Impact
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 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
Condyloform II NFC
SR Orthotyp S
SR Ortholingual S
IPS e.max CAD Abutment Solutions
IPS e.max CAD CER/inLab LT
SR-IVOLEN TRAY MATERIAL
SR-IVOLEN
ProArt CAD Try-In
SR Ivocron
IPS e.max CAD Abutment Solutions- extra systems
ProArt CAD Splint
SR Orthotyp
Candulor brands
SR Vivodent
Preference Posterior
SR Ivostar
Preference Anterior
SR Gnathostar
SR Vivodent A-D
SR Orthotyp A-D
IPS e.max ZirCAD MT Multi blocks
IPS e.max ZirCAD MT discs
IPS e.max ZirCAD Prime Esthetic
IPS Ivocolor
IPS Ivocolor Intro Kit
IPS e.max Ceram Art
Telio CAD Abutment Solutions- extra systems
IPS e.max Ceram Selection
IPS e.max Ceram
IPS Empress Staining
IPS e.max Ceram Power
IPS e.max CAD Crystall Glaze Spray
IPS e.max CAD Crystall Stains
IPS e.max CAD Crystall Shades
IPS e.max CAD Crystall Glaze Paste
IPS e.max Ceram Intro Kit
IPS e.max Ceram Glaze Spray
SR Ivocap
PhysioStar NFC Plus
Bonartic II NFC Plus
Condyloform II NFC Plus
Spartan Solder
Spartan Ceramic Solder
d.SIGN 30
Colado NC
IPS e.max Zirconia
IPS e.max ZirCAD Prime
Telio CAD Abutment Solutions Telio CAD A16
Abutment Solutions for CEREC/InLab Starter Kit
Tetric CAD
Tetric CAD for PlanMill
Tetric CAD for PrograMill Starter Kit
Tetric CAD for CEREC Starter Kit
Ivotion Bond
Ivotion Base
Ivotion
IPS e.max CAD Crystall
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)