Espe Dental Ag
✅ Low Risk
FEI: 3003093965 • Norristown, PA • UNITED STATES
FEI Number
3003093965
Location
Norristown, PA
Country
UNITED STATESAddress
1710 Romano Dr, , Norristown, PA, United States
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 Espe Dental Ag's FDA import refusal history?
Espe Dental Ag (FEI: 3003093965) has 1 FDA import refusal record(s) in our database, spanning from 3/12/2002 to 3/12/2002.
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. Espe Dental Ag's FEI number is 3003093965.
What types of violations has Espe Dental Ag received?
Espe Dental Ag 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 Espe Dental Ag come from?
All FDA import refusal data for Espe Dental Ag 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.