Z Dentamen Instrum
⚠️ Moderate Risk
FEI: 3004039662 • Sialkot • PAKISTAN
FEI Number
3004039662
Location
Sialkot
Country
PAKISTANAddress
Wazirabad Road, , Sialkot, , Pakistan
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
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
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 |
|---|---|---|---|
| 5/31/2006 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/31/2006 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/31/2006 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/18/2004 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Z Dentamen Instrum's FDA import refusal history?
Z Dentamen Instrum (FEI: 3004039662) has 4 FDA import refusal record(s) in our database, spanning from 8/18/2004 to 5/31/2006.
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. Z Dentamen Instrum's FEI number is 3004039662.
What types of violations has Z Dentamen Instrum received?
Z Dentamen Instrum 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 Z Dentamen Instrum come from?
All FDA import refusal data for Z Dentamen Instrum 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.