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Tulsa Dental Products LLC

⚠️ Moderate Risk

FEI: 1000554802 • Johnson City, TN • UNITED STATES

FEI

FEI Number

1000554802

📍

Location

Johnson City, TN

🇺🇸
🏢

Address

608 Rolling Hills Dr, , Johnson City, TN, United States

Moderate Risk

FDA Import Risk Assessment

27.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
4/19/2010
Latest Refusal
11/17/2001
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
3.6×10%
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

1183×

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
4/19/2010
76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
118NOT LISTED
Detroit District Office (DET-DO)
11/28/2001
76DZADRILL, DENTAL, INTRAORAL
118NOT LISTED
Cincinnati District Office (CIN-DO)
11/17/2001
76EKSFILE, PULP CANAL, ENDODONTIC
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Tulsa Dental Products LLC's FDA import refusal history?

Tulsa Dental Products LLC (FEI: 1000554802) has 3 FDA import refusal record(s) in our database, spanning from 11/17/2001 to 4/19/2010.

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. Tulsa Dental Products LLC's FEI number is 1000554802.

What types of violations has Tulsa Dental Products LLC received?

Tulsa Dental Products LLC 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 Tulsa Dental Products LLC come from?

All FDA import refusal data for Tulsa Dental Products LLC 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.