Empress Dental Lab
✅ Low Risk
FEI: 3005048185 • Manila • PHILIPPINES
FEI Number
3005048185
Location
Manila
Country
PHILIPPINESAddress
26th St.Cor 3rd Av, , Manila, , Philippines
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 Empress Dental Lab's FDA import refusal history?
Empress Dental Lab (FEI: 3005048185) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2010 to 10/25/2010.
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. Empress Dental Lab's FEI number is 3005048185.
What types of violations has Empress Dental Lab received?
Empress Dental Lab 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 Empress Dental Lab come from?
All FDA import refusal data for Empress Dental Lab 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.