Jjgc Indutria E Comercio Materiais Dentarios
⚠️ Moderate Risk
FEI: 3008250725 • Curitiba, Parana • BRAZIL
FEI Number
3008250725
Location
Curitiba, Parana
Country
BRAZILAddress
Avenida Visconde de Guarapuava 3832, , 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
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 |
|---|---|---|---|
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/10/2010 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Jjgc Indutria E Comercio Materiais Dentarios's FDA import refusal history?
Jjgc Indutria E Comercio Materiais Dentarios (FEI: 3008250725) has 16 FDA import refusal record(s) in our database, spanning from 5/10/2010 to 5/10/2010.
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. Jjgc Indutria E Comercio Materiais Dentarios's FEI number is 3008250725.
What types of violations has Jjgc Indutria E Comercio Materiais Dentarios received?
Jjgc Indutria E Comercio Materiais Dentarios 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 Jjgc Indutria E Comercio Materiais Dentarios come from?
All FDA import refusal data for Jjgc Indutria E Comercio Materiais Dentarios 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.