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Excel Dental Lab Co., Ltd.

✅ Low Risk

FEI: 3004448728 • Bangkok • THAILAND

FEI

FEI Number

3004448728

📍

Location

Bangkok

🇹🇭

Country

THAILAND
🏢

Address

800/61-62 Soi Trakulsuk, Asoke-Dindang Rd., Dindang, Bangkok, , Thailand

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/17/2004
Latest Refusal
6/17/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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

DateProductViolationsDivision
6/17/2004
76ELLTEETH, PORCELAIN
118NOT LISTED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Excel Dental Lab Co., Ltd.'s FDA import refusal history?

Excel Dental Lab Co., Ltd. (FEI: 3004448728) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2004 to 6/17/2004.

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. Excel Dental Lab Co., Ltd.'s FEI number is 3004448728.

What types of violations has Excel Dental Lab Co., Ltd. received?

Excel Dental Lab Co., 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 Excel Dental Lab Co., Ltd. come from?

All FDA import refusal data for Excel Dental Lab Co., 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.