American Dental Airsonic Technologies, Inc.
✅ Low Risk
FEI: 3008520040 • Corpus Christi, TX • UNITED STATES
FEI Number
3008520040
Location
Corpus Christi, TX
Country
UNITED STATESAddress
5655 Bear Ln Ste 102, , Corpus Christi, TX, 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 American Dental Airsonic Technologies, Inc.'s FDA import refusal history?
American Dental Airsonic Technologies, Inc. (FEI: 3008520040) has 2 FDA import refusal record(s) in our database, spanning from 10/22/2007 to 4/1/2010.
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. American Dental Airsonic Technologies, Inc.'s FEI number is 3008520040.
What types of violations has American Dental Airsonic Technologies, Inc. received?
American Dental Airsonic Technologies, Inc. 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 American Dental Airsonic Technologies, Inc. come from?
All FDA import refusal data for American Dental Airsonic Technologies, Inc. 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.