Spa Dent Inc.
⚠️ Moderate Risk
FEI: 3011050576 • Waterloo, ON • CANADA
FEI Number
3011050576
Location
Waterloo, ON
Country
CANADAAddress
90 Rankin Street Unit 2, , Waterloo, ON, 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).
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 |
|---|---|---|---|
| 10/21/2016 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | Detroit District Office (DET-DO) | |
| 10/21/2016 | 76EHYTRAY, IMPRESSION, PREFORMED | Detroit District Office (DET-DO) | |
| 10/21/2016 | 62FBY47CARBAMIDE PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | Detroit District Office (DET-DO) | |
| 10/21/2016 | 76EIEDAM, RUBBER | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Spa Dent Inc.'s FDA import refusal history?
Spa Dent Inc. (FEI: 3011050576) has 4 FDA import refusal record(s) in our database, spanning from 10/21/2016 to 10/21/2016.
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. Spa Dent Inc.'s FEI number is 3011050576.
What types of violations has Spa Dent Inc. received?
Spa Dent Inc. 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 Spa Dent Inc. come from?
All FDA import refusal data for Spa Dent 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.