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Shioda Dental Corporation

⚠️ Moderate Risk

FEI: 3003587197 • Nasukarasuyama, Tochigi • JAPAN

FEI

FEI Number

3003587197

📍

Location

Nasukarasuyama, Tochigi

🇯🇵

Country

JAPAN
🏢

Address

Minaninasu-Machi 53, Tobara, Nasukarasuyama, Tochigi, Japan

Moderate Risk

FDA Import Risk Assessment

28.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
2
Unique Violations
9/27/2004
Latest Refusal
9/27/2004
Earliest Refusal

Score Breakdown

Violation Severity
36.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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).

4761×

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).

Refusal History

DateProductViolationsDivision
9/27/2004
76EFLFORCEPS, DRESSING, DENTAL
476NO REGISTR
Los Angeles District Office (LOS-DO)
9/27/2004
75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
341REGISTERED
Los Angeles District Office (LOS-DO)
9/27/2004
75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
341REGISTERED
Los Angeles District Office (LOS-DO)
9/27/2004
75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
341REGISTERED
Los Angeles District Office (LOS-DO)
9/27/2004
75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shioda Dental Corporation's FDA import refusal history?

Shioda Dental Corporation (FEI: 3003587197) has 5 FDA import refusal record(s) in our database, spanning from 9/27/2004 to 9/27/2004.

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. Shioda Dental Corporation's FEI number is 3003587197.

What types of violations has Shioda Dental Corporation received?

Shioda Dental Corporation 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 Shioda Dental Corporation come from?

All FDA import refusal data for Shioda Dental Corporation 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.