Dental Devices
⚠️ Moderate Risk
FEI: 3007495996 • Sialkot, Punjab • PAKISTAN
FEI Number
3007495996
Location
Sialkot, Punjab
Country
PAKISTANAddress
Harrar Roras 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
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).
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 |
|---|---|---|---|
| 10/6/2009 | 76DZPINSTRUMENT, DIAMOND, DENTAL | New Orleans District Office (NOL-DO) | |
| 10/6/2009 | 76EMJELEVATOR, SURGICAL, DENTAL | New Orleans District Office (NOL-DO) | |
| 10/6/2009 | 76EMEPUNCH, BIOPSY, SURGICAL | New Orleans District Office (NOL-DO) | |
| 10/6/2009 | 76EIGRETRACTOR, ALL TYPES | New Orleans District Office (NOL-DO) | |
| 10/6/2009 | 76LCNSCRAPER, TONGUE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Dental Devices's FDA import refusal history?
Dental Devices (FEI: 3007495996) has 5 FDA import refusal record(s) in our database, spanning from 10/6/2009 to 10/6/2009.
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. Dental Devices's FEI number is 3007495996.
What types of violations has Dental Devices received?
Dental Devices 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 Dental Devices come from?
All FDA import refusal data for Dental Devices 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.