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Zimmer Dental Inc

⚠️ Moderate Risk

FEI: 2023141 • Carlsbad, CA • UNITED STATES

FEI

FEI Number

2023141

📍

Location

Carlsbad, CA

🇺🇸
🏢

Address

1900 Aston Ave, , Carlsbad, CA, United States

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
12/14/2023
Latest Refusal
12/14/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
43.6×20%
Frequency
40.0×10%
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

1184×

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
12/14/2023
76KLEAGENT, TOOTH BONDING, RESIN
118NOT LISTED
Division of Northern Border Imports (DNBI)
12/14/2023
76KLEAGENT, TOOTH BONDING, RESIN
118NOT LISTED
Division of Northern Border Imports (DNBI)
12/14/2023
76EBGCROWN AND BRIDGE, TEMPORARY, RESIN
118NOT LISTED
Division of Northern Border Imports (DNBI)
12/14/2023
76EBFMATERIAL, TOOTH SHADE, RESIN
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Zimmer Dental Inc's FDA import refusal history?

Zimmer Dental Inc (FEI: 2023141) has 4 FDA import refusal record(s) in our database, spanning from 12/14/2023 to 12/14/2023.

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. Zimmer Dental Inc's FEI number is 2023141.

What types of violations has Zimmer Dental Inc received?

Zimmer Dental 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 Zimmer Dental Inc come from?

All FDA import refusal data for Zimmer Dental 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.