National Dental Inc
⚠️ Moderate Risk
FEI: 3004631559 • Barrie, Ontario • CANADA
FEI Number
3004631559
Location
Barrie, Ontario
Country
CANADAAddress
3-149 Collier St, , Barrie, 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
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2020 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | Division of Northern Border Imports (DNBI) | |
| 1/24/2014 | 79KQMCAMERA, SURGICAL AND ACCESSORIES | New York District Office (NYK-DO) | |
| 6/18/2012 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | New Orleans District Office (NOL-DO) | |
| 12/12/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 76EIAUNIT, OPERATIVE DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/21/2005 | 76NOFSYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) OF DENTAL RESTORATI | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is National Dental Inc's FDA import refusal history?
National Dental Inc (FEI: 3004631559) has 6 FDA import refusal record(s) in our database, spanning from 7/21/2005 to 7/21/2020.
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. National Dental Inc's FEI number is 3004631559.
What types of violations has National Dental Inc received?
National Dental Inc 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 National Dental Inc come from?
All FDA import refusal data for National Dental Inc 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.