ADIN DENTAL IMPLANTS SYSTEM LTD
✅ Low Risk
FEI: 3007518363 • Alon Tavor • ISRAEL
FEI Number
3007518363
Location
Alon Tavor
Country
ISRAELAddress
Industrial Zone, , Alon Tavor, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2014 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ADIN DENTAL IMPLANTS SYSTEM LTD's FDA import refusal history?
ADIN DENTAL IMPLANTS SYSTEM LTD (FEI: 3007518363) has 1 FDA import refusal record(s) in our database, spanning from 8/11/2014 to 8/11/2014.
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. ADIN DENTAL IMPLANTS SYSTEM LTD's FEI number is 3007518363.
What types of violations has ADIN DENTAL IMPLANTS SYSTEM LTD received?
ADIN DENTAL IMPLANTS SYSTEM LTD 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 ADIN DENTAL IMPLANTS SYSTEM LTD come from?
All FDA import refusal data for ADIN DENTAL IMPLANTS SYSTEM 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.