American Dental Trading Bv
⚠️ Moderate Risk
FEI: 3004961705 • Oisterwijk, Noord-Brabant • NETHERLANDS
FEI Number
3004961705
Location
Oisterwijk, Noord-Brabant
Country
NETHERLANDSAddress
Laarakkerweg 5, , Oisterwijk, Noord-Brabant, Netherlands
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/25/2006 | 76NEACEMENT, EAR, NOSE AND THROAT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is American Dental Trading Bv's FDA import refusal history?
American Dental Trading Bv (FEI: 3004961705) has 16 FDA import refusal record(s) in our database, spanning from 3/25/2006 to 3/25/2006.
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 Trading Bv's FEI number is 3004961705.
What types of violations has American Dental Trading Bv received?
American Dental Trading Bv 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 Trading Bv come from?
All FDA import refusal data for American Dental Trading Bv 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.