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Dental EZ Group Star Dental Division

✅ Low Risk

FEI: 2520265 • Lancaster, PA • UNITED STATES

FEI

FEI Number

2520265

📍

Location

Lancaster, PA

🇺🇸
🏢

Address

1816 Colonial Village Ln, , Lancaster, PA, 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
5/19/2011
Latest Refusal
5/19/2011
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
5/19/2011
76EFAHANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL
118NOT LISTED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Dental EZ Group Star Dental Division's FDA import refusal history?

Dental EZ Group Star Dental Division (FEI: 2520265) has 1 FDA import refusal record(s) in our database, spanning from 5/19/2011 to 5/19/2011.

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 EZ Group Star Dental Division's FEI number is 2520265.

What types of violations has Dental EZ Group Star Dental Division received?

Dental EZ Group Star Dental Division 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 Dental EZ Group Star Dental Division come from?

All FDA import refusal data for Dental EZ Group Star Dental Division 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.