Jjgc Industria E Comercio Materiais Dentarios
✅ Low Risk
FEI: 3006471423 • Curitiba, Parana • BRAZIL
FEI Number
3006471423
Location
Curitiba, Parana
Country
BRAZILAddress
Rua Angelo Domingos Durigan 607, , Curitiba, Parana, Brazil
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Jjgc Industria E Comercio Materiais Dentarios's FDA import refusal history?
Jjgc Industria E Comercio Materiais Dentarios (FEI: 3006471423) has 2 FDA import refusal record(s) in our database, spanning from 8/25/2008 to 8/25/2008.
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 Industria E Comercio Materiais Dentarios's FEI number is 3006471423.
What types of violations has Jjgc Industria E Comercio Materiais Dentarios received?
Jjgc Industria E Comercio Materiais Dentarios has been cited for 2 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 Industria E Comercio Materiais Dentarios come from?
All FDA import refusal data for Jjgc Industria 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.