DENTAL AGUIAR COM DE PROD ODON
⚠️ Moderate Risk
FEI: 3012612743 • Curitiba, Parana • BRAZIL
FEI Number
3012612743
Location
Curitiba, Parana
Country
BRAZILAddress
Avenida Marechal Floriano Peixoto, 306 Sala -26/27, , Curitiba, Parana, Brazil
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
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 |
|---|---|---|---|
| 9/30/2018 | 76DZCWIRE, ORTHODONTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/30/2018 | 76EJFBRACKET, METAL, ORTHODONTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/30/2018 | 76ECIBAND, ELASTIC, ORTHODONTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/30/2018 | 76DYOBAND, MATERIAL, ORTHODONTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DENTAL AGUIAR COM DE PROD ODON's FDA import refusal history?
DENTAL AGUIAR COM DE PROD ODON (FEI: 3012612743) has 4 FDA import refusal record(s) in our database, spanning from 9/30/2018 to 9/30/2018.
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 AGUIAR COM DE PROD ODON's FEI number is 3012612743.
What types of violations has DENTAL AGUIAR COM DE PROD ODON received?
DENTAL AGUIAR COM DE PROD ODON 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 AGUIAR COM DE PROD ODON come from?
All FDA import refusal data for DENTAL AGUIAR COM DE PROD ODON 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.