Ivoclar Vivadent AG
⚠️ High Risk
FEI: 3002808636 • Schaan • LIECHTENSTEIN
FEI Number
3002808636
Location
Schaan
Country
LIECHTENSTEINAddress
Benderer Strasse 2, , Schaan, , Liechtenstein
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2024 | 76EIHPOWDER, PORCELAIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/18/2023 | 76PEMDENTAL BARRIERS AND SLEEVES | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76ELLTEETH, PORCELAIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EMACEMENT, DENTAL | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EMACEMENT, DENTAL | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EIHPOWDER, PORCELAIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76ELWMATERIAL, IMPRESSION | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | Division of Northeast Imports (DNEI) | |
| 10/18/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 8/5/2019 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Southeast Imports (DSEI) | |
| 2/12/2019 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 1/9/2018 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Division of Northeast Imports (DNEI) | |
| 4/1/2010 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 10/8/2009 | 76EMACEMENT, DENTAL | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 10/8/2009 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 10/8/2009 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 10/3/2006 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ivoclar Vivadent AG's FDA import refusal history?
Ivoclar Vivadent AG (FEI: 3002808636) has 28 FDA import refusal record(s) in our database, spanning from 10/3/2006 to 8/19/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ivoclar Vivadent AG's FEI number is 3002808636.
What types of violations has Ivoclar Vivadent AG received?
Ivoclar Vivadent AG has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Ivoclar Vivadent AG come from?
All FDA import refusal data for Ivoclar Vivadent AG is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.