Ivoclar Vivadent, Inc.
✅ Low Risk
FEI: 1316092 • Amherst, NY • UNITED STATES
FEI Number
1316092
Location
Amherst, NY
Country
UNITED STATESAddress
175 Pineview Dr, , Amherst, NY, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/5/2016 | 76EIHPOWDER, PORCELAIN | Division of Northeast Imports (DNEI) | |
| 10/5/2016 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Division of Northeast Imports (DNEI) | |
| 12/8/2010 | 76EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ivoclar Vivadent, Inc.'s FDA import refusal history?
Ivoclar Vivadent, Inc. (FEI: 1316092) has 3 FDA import refusal record(s) in our database, spanning from 12/8/2010 to 10/5/2016.
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, Inc.'s FEI number is 1316092.
What types of violations has Ivoclar Vivadent, Inc. received?
Ivoclar Vivadent, Inc. has been cited for 2 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, Inc. come from?
All FDA import refusal data for Ivoclar Vivadent, Inc. 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.