FDA Registration
Active
🇺🇸 United States
IVOCLAR VIVADENT, INC.
Reg #: 1316092
·
FEI: 1316092
·
Expires 2026
Products
11
Proprietary Names
91
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- IVOCLAR VIVADENT, INC.
- Registration Number
- 1316092
- FEI Number
- 1316092
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 175 PINEVIEW DR.
- City
- AMHERST
- State
- NY
- ZIP
- 14228
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080130
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2010-11-23 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2021-03-03 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2006-10-20 |
| Alloy, Amalgam | EJJ | Class 2 | Dental | No | 2007-11-14 |
| Alloy, Other Noble Metal | EJS | Class 2 | Dental | No | 2001-10-25 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2019-02-25 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2005-07-05 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 1990-04-16 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2007-01-31 |
| Alloy, Gold-Based Noble Metal | EJT | Class 2 | Dental | No | 2001-10-30 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2022-02-21 |
Proprietary Names
Virtual CADbite
ZirCAD Cement
Spartan Solder
Spartan Ceramic Solder
d.SIGN 30
Colado NC
Valiant PhD
AccuDent XD Tray Material
AccuDent XD Syringe Material
Capricorn 15
Universal Solder 1015 W
Super Solder Ceramic Solder
Elektra
Evolution Lite
Solarcast 20
W-3
d.SIGN 91
Laser C&B White
d.SIGN 53
IS-64
Aquarius
Magenta
d.SIGN 59
Laser C&B Yellow
Aquarius Ceramic Solder
Special High Fusing White Ceramic Solder
Harmony X-Hard
d.SIGN 67
W-2
Lodestar
Universal Solder PKF
Harmony 2
Rim Former New
Bite Gauge
Bite Plane
Virtual Dispenser
Dispenser
ZirCAD Cement Mixing Tips
VivaPen Snap On Cannulas
Vivadent Applicator
Virtual Tips
Variolink Application Tips
Multilink Applicator
Root Canal Tips
Mixing Cannulas
Intraoral Tips
Mixing Tips
AccuDent XD Impression Tray
Centric Tray
AccuDent XD Tray Adhesive
Aesthetic Wax
Virtual
XL-X
HIgh Fusing Yellow Ceramic Solder
Academy Gold XH
Callisto Implant 33
Laser Ceramic Yellow Pdf
Golden Ceramic Solder
Harmony Medium
Harmony Hard
Brite Gold
Maxigold KF
Academy Gold
Laser Ceramic Yellow
Y
.585 Fine Gold Solder
Low Fusing White Gold Solder
W
W-1
d.SIGN 98
W-5
d.SIGN 96
HGPKF 1030 Y Solder
.615 Fine Gold Solder
X-L
Y-1
Laser Ceramic White
High Fusing White Ceramic Solder
Midigold 50
Maxigold
Minigold
Aquarius Hard
Callisto 75 Pd
HGPKF 1015 Y Solder
Harmony C & B 55
Spartan Plus
.650 Fine Gold Solder
Callisto CPG
Valiant
Valiant Sure-Cap
VivaStyle Whitening LED Kit
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198