UNIQA DENTAL

⚠️ High Risk

FEI: 3017296154 • Netanya • ISRAEL

FEI

FEI Number

3017296154

📍

Location

Netanya

🇮🇱

Country

ISRAEL

🏢

Address

2, Ha-Tsoran, Floor, Netanya, , Israel

High Risk

FDA Import Risk Assessment

63.5

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

7/14/2025

Latest Refusal

2/6/2025

Earliest Refusal

Score Breakdown

Violation Severity

51.4×40%

Refusal Volume

49.7×30%

Recency

90.1×20%

Frequency

100.0×10%

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

Violation Summary

47615×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

3416×

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
7/14/2025	76DZEIMPLANT, ENDOSSEOUS	341REGISTERED	Division of Northeast Imports (DNEI)
7/14/2025	76DZEIMPLANT, ENDOSSEOUS	341REGISTERED	Division of Northeast Imports (DNEI)
7/14/2025	76DZEIMPLANT, ENDOSSEOUS	341REGISTERED	Division of Northeast Imports (DNEI)
7/14/2025	76DZEIMPLANT, ENDOSSEOUS	341REGISTERED	Division of Northeast Imports (DNEI)
7/14/2025	76DZEIMPLANT, ENDOSSEOUS	341REGISTERED	Division of Northeast Imports (DNEI)
7/14/2025	76DZEIMPLANT, ENDOSSEOUS	341REGISTERED	Division of Northeast Imports (DNEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)
2/6/2025	76DZEIMPLANT, ENDOSSEOUS	476NO REGISTR	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is UNIQA DENTAL's FDA import refusal history?

UNIQA DENTAL (FEI: 3017296154) has 21 FDA import refusal record(s) in our database, spanning from 2/6/2025 to 7/14/2025.

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. UNIQA DENTAL's FEI number is 3017296154.

What types of violations has UNIQA DENTAL received?

UNIQA DENTAL 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 UNIQA DENTAL come from?

All FDA import refusal data for UNIQA DENTAL 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.