By Dental Srl
⚠️ Moderate Risk
FEI: 3008293162 • Serravalle Pistoiese, Pt • ITALY
FEI Number
3008293162
Location
Serravalle Pistoiese, Pt
Country
ITALYAddress
49 F Via Vecchia Provinciale Lucchese S, , Serravalle Pistoiese, Pt, Italy
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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is By Dental Srl's FDA import refusal history?
By Dental Srl (FEI: 3008293162) has 2 FDA import refusal record(s) in our database, spanning from 5/29/2012 to 5/29/2012.
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. By Dental Srl's FEI number is 3008293162.
What types of violations has By Dental Srl received?
By Dental Srl has been cited for 3 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 By Dental Srl come from?
All FDA import refusal data for By Dental Srl 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.