Bolton Buffalo Dental
⚠️ Moderate Risk
FEI: 3002909111 • Cambridge, Ontario • CANADA
FEI Number
3002909111
Location
Cambridge, Ontario
Country
CANADAAddress
50 Goebel Ave, , Cambridge, Ontario, Canada
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
Frequently Asked Questions
What is Bolton Buffalo Dental's FDA import refusal history?
Bolton Buffalo Dental (FEI: 3002909111) has 2 FDA import refusal record(s) in our database, spanning from 10/20/2006 to 10/20/2006.
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. Bolton Buffalo Dental's FEI number is 3002909111.
What types of violations has Bolton Buffalo Dental received?
Bolton Buffalo Dental has been cited for 1 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 Bolton Buffalo Dental come from?
All FDA import refusal data for Bolton Buffalo Dental 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.