Cavex Holland B.V.
⚠️ Moderate Risk
FEI: 3008898734 • Haarlem, Noord-Holland • NETHERLANDS
FEI Number
3008898734
Location
Haarlem, Noord-Holland
Country
NETHERLANDSAddress
Fustweg 5, , Haarlem, Noord-Holland, Netherlands
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | 341REGISTERED | San Juan District Office (SJN-DO) |
| 8/31/2015 | 76EBCSEALANT, PIT AND FISSURE, AND CONDITIONER | 341REGISTERED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Cavex Holland B.V.'s FDA import refusal history?
Cavex Holland B.V. (FEI: 3008898734) has 8 FDA import refusal record(s) in our database, spanning from 8/31/2015 to 8/31/2015.
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. Cavex Holland B.V.'s FEI number is 3008898734.
What types of violations has Cavex Holland B.V. received?
Cavex Holland B.V. 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 Cavex Holland B.V. come from?
All FDA import refusal data for Cavex Holland B.V. 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.