3M Espe Dental Products
⚠️ High Risk
FEI: 2020493 • Irvine, CA • UNITED STATES
FEI Number
2020493
Location
Irvine, CA
Country
UNITED STATESAddress
2111 Mcgaw Ave, , Irvine, CA, United States
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2025 | 76EMACEMENT, DENTAL | Division of Northeast Imports (DNEI) | |
| 10/24/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 9/23/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Southeast Imports (DSEI) | |
| 9/5/2025 | 76EMACEMENT, DENTAL | Division of Northeast Imports (DNEI) | |
| 5/2/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 1/7/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | 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) |
| 7/14/2022 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Southeast Imports (DSEI) | |
| 9/15/2017 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EMACEMENT, DENTAL | Division of Northern Border Imports (DNBI) | |
| 4/7/2011 | 76EMACEMENT, DENTAL | New York District Office (NYK-DO) | |
| 4/7/2011 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) |
Frequently Asked Questions
What is 3M Espe Dental Products's FDA import refusal history?
3M Espe Dental Products (FEI: 2020493) has 13 FDA import refusal record(s) in our database, spanning from 4/7/2011 to 11/12/2025.
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. 3M Espe Dental Products's FEI number is 2020493.
What types of violations has 3M Espe Dental Products received?
3M Espe Dental Products 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 3M Espe Dental Products come from?
All FDA import refusal data for 3M Espe Dental Products 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.