La Dental De Mariano Lioi
⚠️ Moderate Risk
FEI: 3004999773 • Ciudad Autonoma Buenos Aires, Buenos Aires • ARGENTINA
FEI Number
3004999773
Location
Ciudad Autonoma Buenos Aires, Buenos Aires
Country
ARGENTINAAddress
Calle San Martin 693, , Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
| 4/22/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is La Dental De Mariano Lioi's FDA import refusal history?
La Dental De Mariano Lioi (FEI: 3004999773) has 7 FDA import refusal record(s) in our database, spanning from 4/22/2005 to 4/22/2005.
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. La Dental De Mariano Lioi's FEI number is 3004999773.
What types of violations has La Dental De Mariano Lioi received?
La Dental De Mariano Lioi 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 La Dental De Mariano Lioi come from?
All FDA import refusal data for La Dental De Mariano Lioi 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.