Solaris Dental Design
✅ Low Risk
FEI: 3009303905 • Coquitlam, BC • CANADA
FEI Number
3009303905
Location
Coquitlam, BC
Country
CANADAAddress
101 17 Fawcett Rd, , Coquitlam, BC, Canada
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 Solaris Dental Design's FDA import refusal history?
Solaris Dental Design (FEI: 3009303905) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2012 to 1/4/2012.
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. Solaris Dental Design's FEI number is 3009303905.
What types of violations has Solaris Dental Design received?
Solaris Dental Design 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 Solaris Dental Design come from?
All FDA import refusal data for Solaris Dental Design 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.