Dental Technologies Inc.
⚠️ Moderate Risk
FEI: 1413475 • Lincolnwood, IL • UNITED STATES
FEI Number
1413475
Location
Lincolnwood, IL
Country
UNITED STATESAddress
6901 N Hamlin Ave, , Lincolnwood, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2022 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 2/1/2022 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 2/1/2022 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 8/12/2021 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 8/12/2021 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 8/12/2021 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Dental Technologies Inc.'s FDA import refusal history?
Dental Technologies Inc. (FEI: 1413475) has 6 FDA import refusal record(s) in our database, spanning from 8/12/2021 to 2/1/2022.
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. Dental Technologies Inc.'s FEI number is 1413475.
What types of violations has Dental Technologies Inc. received?
Dental Technologies 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 Dental Technologies Inc. come from?
All FDA import refusal data for Dental Technologies 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.