Southern Dental Industries Inc
⚠️ Moderate Risk
FEI: 1000124094 • Itasca, IL • UNITED STATES
FEI Number
1000124094
Location
Itasca, IL
Country
UNITED STATESAddress
1279 Hamilton Pkwy, , Itasca, IL, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 2/5/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 2/5/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 2/5/2014 | 76EJJALLOY, AMALGAM | Division of Northeast Imports (DNEI) | |
| 2/5/2014 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 11/23/2009 | 76EJJALLOY, AMALGAM | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 11/23/2009 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 11/23/2009 | 76EJJALLOY, AMALGAM | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Southern Dental Industries Inc's FDA import refusal history?
Southern Dental Industries Inc (FEI: 1000124094) has 7 FDA import refusal record(s) in our database, spanning from 11/23/2009 to 2/5/2014.
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. Southern Dental Industries Inc's FEI number is 1000124094.
What types of violations has Southern Dental Industries Inc received?
Southern Dental Industries 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 Southern Dental Industries Inc come from?
All FDA import refusal data for Southern Dental Industries 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.