Cepillos Dentales Sa
✅ Low Risk
FEI: 3004940764 • Guatemala City • GUATEMALA
FEI Number
3004940764
Location
Guatemala City
Country
GUATEMALAAddress
Primera Avenida 3400, , Guatemala City, , Guatemala
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).
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
Frequently Asked Questions
What is Cepillos Dentales Sa's FDA import refusal history?
Cepillos Dentales Sa (FEI: 3004940764) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2005 to 2/3/2005.
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. Cepillos Dentales Sa's FEI number is 3004940764.
What types of violations has Cepillos Dentales Sa received?
Cepillos Dentales Sa 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 Cepillos Dentales Sa come from?
All FDA import refusal data for Cepillos Dentales Sa 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.