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Young Dental Manufacturing I, LLC

✅ Low Risk

FEI: 1941138 • Earth City, MO • UNITED STATES

FEI

FEI Number

1941138

📍

Location

Earth City, MO

🇺🇸
🏢

Address

13705 Shoreline Ct E, , Earth City, MO, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/18/2020
Latest Refusal
11/18/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

Refusal History

DateProductViolationsDivision
11/18/2020
76EJLBUR, DENTAL
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Young Dental Manufacturing I, LLC's FDA import refusal history?

Young Dental Manufacturing I, LLC (FEI: 1941138) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2020 to 11/18/2020.

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. Young Dental Manufacturing I, LLC's FEI number is 1941138.

What types of violations has Young Dental Manufacturing I, LLC received?

Young Dental Manufacturing I, LLC has been cited for 1 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 Young Dental Manufacturing I, LLC come from?

All FDA import refusal data for Young Dental Manufacturing I, LLC 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.