ImportRefusal LogoImportRefusal

DITRON PRECISION

✅ Low Risk

FEI: 3013009601 • Ashkelon • ISRAEL

FEI

FEI Number

3013009601

📍

Location

Ashkelon

🇮🇱

Country

ISRAEL
🏢

Address

2, Ha-Ofe, , Ashkelon, , Israel

Low Risk

FDA Import Risk Assessment

23.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

4
Total Refusals
1
Unique Violations
12/27/2016
Latest Refusal
12/27/2016
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3414×

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

DateProductViolationsDivision
12/27/2016
76DZEIMPLANT, ENDOSSEOUS
341REGISTERED
Cincinnati District Office (CIN-DO)
12/27/2016
76DZEIMPLANT, ENDOSSEOUS
341REGISTERED
Cincinnati District Office (CIN-DO)
12/27/2016
76DZEIMPLANT, ENDOSSEOUS
341REGISTERED
Cincinnati District Office (CIN-DO)
12/27/2016
76DZEIMPLANT, ENDOSSEOUS
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is DITRON PRECISION's FDA import refusal history?

DITRON PRECISION (FEI: 3013009601) has 4 FDA import refusal record(s) in our database, spanning from 12/27/2016 to 12/27/2016.

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. DITRON PRECISION's FEI number is 3013009601.

What types of violations has DITRON PRECISION received?

DITRON PRECISION 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 DITRON PRECISION come from?

All FDA import refusal data for DITRON PRECISION 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.