Biomet 3i Dental Iberica SLU
⚠️ Moderate Risk
FEI: 3009840806 • Paterna, Valencia • SPAIN
FEI Number
3009840806
Location
Paterna, Valencia
Country
SPAINAddress
Pol. Ind. Fuente del Jarro, Calle Islas Baleares 50, Paterna, Valencia, Spain
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
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.
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 Biomet 3i Dental Iberica SLU's FDA import refusal history?
Biomet 3i Dental Iberica SLU (FEI: 3009840806) has 2 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 5/30/2006.
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. Biomet 3i Dental Iberica SLU's FEI number is 3009840806.
What types of violations has Biomet 3i Dental Iberica SLU received?
Biomet 3i Dental Iberica SLU 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 Biomet 3i Dental Iberica SLU come from?
All FDA import refusal data for Biomet 3i Dental Iberica SLU 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.