ImportRefusal LogoImportRefusal

Densply Sirona Orthodontics Inc.

⚠️ Moderate Risk

FEI: 1036212 • Sarasota, FL • UNITED STATES

FEI

FEI Number

1036212

📍

Location

Sarasota, FL

🇺🇸
🏢

Address

7290 26th Ct E, , Sarasota, FL, United States

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/23/2004
Latest Refusal
11/22/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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
11/23/2004
76ECQALIGNER, BRACKET, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)
11/22/2004
76DZCWIRE, ORTHODONTIC
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Densply Sirona Orthodontics Inc.'s FDA import refusal history?

Densply Sirona Orthodontics Inc. (FEI: 1036212) has 2 FDA import refusal record(s) in our database, spanning from 11/22/2004 to 11/23/2004.

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. Densply Sirona Orthodontics Inc.'s FEI number is 1036212.

What types of violations has Densply Sirona Orthodontics Inc. received?

Densply Sirona Orthodontics Inc. 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 Densply Sirona Orthodontics Inc. come from?

All FDA import refusal data for Densply Sirona Orthodontics Inc. 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.