EON DENTAL JORDAN
⚠️ Moderate Risk
FEI: 3026845643 • Amman • JORDAN
FEI Number
3026845643
Location
Amman
Country
JORDANAddress
Road 7 General Storage, , Amman, , Jordan
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
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
Frequently Asked Questions
What is EON DENTAL JORDAN's FDA import refusal history?
EON DENTAL JORDAN (FEI: 3026845643) has 2 FDA import refusal record(s) in our database, spanning from 1/26/2024 to 1/26/2024.
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. EON DENTAL JORDAN's FEI number is 3026845643.
What types of violations has EON DENTAL JORDAN received?
EON DENTAL JORDAN 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 EON DENTAL JORDAN come from?
All FDA import refusal data for EON DENTAL JORDAN 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.