Dentium Co
✅ Low Risk
FEI: 3008553372 • Seoul, Seoul • SOUTH KOREA
FEI Number
3008553372
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
Kuro 3 Dong 1106, , Seoul, Seoul, South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/30/2012 | 76LYCBONE GRAFTING MATERIAL, SYNTHETIC | 341REGISTERED | New York District Office (NYK-DO) |
| 3/30/2012 | 76NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | New York District Office (NYK-DO) |
| 3/30/2012 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | New York District Office (NYK-DO) |
| 3/30/2012 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dentium Co's FDA import refusal history?
Dentium Co (FEI: 3008553372) has 4 FDA import refusal record(s) in our database, spanning from 3/30/2012 to 3/30/2012.
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. Dentium Co's FEI number is 3008553372.
What types of violations has Dentium Co received?
Dentium Co 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 Dentium Co come from?
All FDA import refusal data for Dentium Co 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.