Paltop Advanced Dental Solutions Ltd
✅ Low Risk
FEI: 3009161350 • Caesarea • ISRAEL
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2019 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/7/2019 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/7/2019 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/10/2014 | 76DZADRILL, DENTAL, INTRAORAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Paltop Advanced Dental Solutions Ltd's FDA import refusal history?
Paltop Advanced Dental Solutions Ltd (FEI: 3009161350) has 4 FDA import refusal record(s) in our database, spanning from 1/10/2014 to 11/7/2019.
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. Paltop Advanced Dental Solutions Ltd's FEI number is 3009161350.
What types of violations has Paltop Advanced Dental Solutions Ltd received?
Paltop Advanced Dental Solutions Ltd 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 Paltop Advanced Dental Solutions Ltd come from?
All FDA import refusal data for Paltop Advanced Dental Solutions Ltd 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.