Shofu Dental Mfg Co Ltd
✅ Low Risk
FEI: 3003446291 • Kyoto -Shi • JAPAN
FEI Number
3003446291
Location
Kyoto -Shi
Country
JAPANAddress
Unknown Street, , Kyoto -Shi, , Japan
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2002 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shofu Dental Mfg Co Ltd's FDA import refusal history?
Shofu Dental Mfg Co Ltd (FEI: 3003446291) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2002 to 11/18/2002.
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. Shofu Dental Mfg Co Ltd's FEI number is 3003446291.
What types of violations has Shofu Dental Mfg Co Ltd received?
Shofu Dental Mfg Co Ltd 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 Shofu Dental Mfg Co Ltd come from?
All FDA import refusal data for Shofu Dental Mfg Co Ltd 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.