World Medical Dent
⚠️ Moderate Risk
FEI: 3003905401 • Sialkot, Punjab • PAKISTAN
FEI Number
3003905401
Location
Sialkot, Punjab
Country
PAKISTANAddress
Nasir Road, , Sialkot, Punjab, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2007 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 79HTCPLIERS, SURGICAL | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 76EKBEXPLORER, OPERATIVE | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 76EMJELEVATOR, SURGICAL, DENTAL | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 76EKBEXPLORER, OPERATIVE | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 76EIRSCISSORS, COLLAR AND CROWN | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 76EHYTRAY, IMPRESSION, PREFORMED | Los Angeles District Office (LOS-DO) | |
| 7/26/2007 | 79HTDFORCEPS | Los Angeles District Office (LOS-DO) | |
| 11/29/2005 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | Florida District Office (FLA-DO) |
| 11/29/2005 | 76EMSCURETTE, PERIODONTIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/29/2005 | 76JEPRETAINER, MATRIX | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/29/2005 | 76EIXPROBE, PERIODONTIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/29/2005 | 76EISREMOVER, CROWN | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/29/2005 | 76EJISYRINGE, CARTRIDGE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is World Medical Dent's FDA import refusal history?
World Medical Dent (FEI: 3003905401) has 15 FDA import refusal record(s) in our database, spanning from 11/29/2005 to 7/26/2007.
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. World Medical Dent's FEI number is 3003905401.
What types of violations has World Medical Dent received?
World Medical Dent 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 World Medical Dent come from?
All FDA import refusal data for World Medical Dent 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.