KURARAY NORITAKE DENTAL NIIGATA PLANT
⚠️ High Risk
FEI: 3002807420 • Tainai, Niigata • JAPAN
FEI Number
3002807420
Location
Tainai, Niigata
Country
JAPANAddress
2-28, Kurashiki-Cho, Tainai, Niigata, Japan
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2026 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 11/12/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 9/5/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Northeast Imports (DNEI) | |
| 9/5/2025 | 76LFCDEVICE, CARRIES DETECTION | Division of Northeast Imports (DNEI) | |
| 8/19/2024 | 76EMACEMENT, DENTAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | 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 | 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 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76EMACEMENT, DENTAL | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76KLEAGENT, TOOTH BONDING, RESIN | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/19/2024 | 76LBHVARNISH, CAVITY | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/18/2023 | 76KLEAGENT, TOOTH BONDING, 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 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is KURARAY NORITAKE DENTAL NIIGATA PLANT's FDA import refusal history?
KURARAY NORITAKE DENTAL NIIGATA PLANT (FEI: 3002807420) has 19 FDA import refusal record(s) in our database, spanning from 10/18/2023 to 1/7/2026.
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. KURARAY NORITAKE DENTAL NIIGATA PLANT's FEI number is 3002807420.
What types of violations has KURARAY NORITAKE DENTAL NIIGATA PLANT received?
KURARAY NORITAKE DENTAL NIIGATA PLANT has been cited for 3 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 KURARAY NORITAKE DENTAL NIIGATA PLANT come from?
All FDA import refusal data for KURARAY NORITAKE DENTAL NIIGATA PLANT 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.