Bien Air Dental SA
✅ Low Risk
FEI: 3002762033 • Biel/bienne, Be • SWITZERLAND
FEI Number
3002762033
Location
Biel/bienne, Be
Country
SWITZERLANDAddress
Langgasse 60, , Biel/bienne, Be, Switzerland
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2019 | 76PMEEXTERNAL CLEANING SOLUTION | Division of Southeast Imports (DSEI) | |
| 1/20/2017 | 76DZIDRILL, BONE, POWERED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/24/2011 | 76EFBHANDPIECE, AIR-POWERED, DENTAL | New Orleans District Office (NOL-DO) | |
| 8/24/2011 | 76EFBHANDPIECE, AIR-POWERED, DENTAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bien Air Dental SA's FDA import refusal history?
Bien Air Dental SA (FEI: 3002762033) has 4 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 8/26/2019.
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. Bien Air Dental SA's FEI number is 3002762033.
What types of violations has Bien Air Dental SA received?
Bien Air Dental 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 Bien Air Dental SA come from?
All FDA import refusal data for Bien Air Dental 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.