Dentsply Detrey

⚠️ Moderate Risk

FEI: 3000274105 • Konstanz • GERMANY

FEI

FEI Number

3000274105

📍

Location

Konstanz

🇩🇪

Country

GERMANY

🏢

Address

Postfach 1004, , Konstanz, , Germany

Moderate Risk

FDA Import Risk Assessment

30.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/23/2014

Latest Refusal

6/19/2006

Earliest Refusal

Score Breakdown

Violation Severity

46.4×40%

Refusal Volume

35.3×30%

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

Violation Summary

1185×

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).

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).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
6/23/2014	76EIHPOWDER, PORCELAIN	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
1/30/2012	76EMACEMENT, DENTAL	341REGISTERED	Detroit District Office (DET-DO)
8/6/2010	76EMACEMENT, DENTAL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/1/2008	76EBFMATERIAL, TOOTH SHADE, RESIN	341REGISTERED	Detroit District Office (DET-DO)
3/1/2007	76NSMRESTORATION, RESIN	341REGISTERED 508NO 510(K)	New York District Office (NYK-DO)
6/28/2006	76EMACEMENT, DENTAL	118NOT LISTED	New York District Office (NYK-DO)
6/19/2006	76EMACEMENT, DENTAL	118NOT LISTED	New York District Office (NYK-DO)
6/19/2006	76EMACEMENT, DENTAL	118NOT LISTED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Dentsply Detrey's FDA import refusal history?

Dentsply Detrey (FEI: 3000274105) has 8 FDA import refusal record(s) in our database, spanning from 6/19/2006 to 6/23/2014.

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. Dentsply Detrey's FEI number is 3000274105.

What types of violations has Dentsply Detrey received?

Dentsply Detrey has been cited for 3 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 Dentsply Detrey come from?

All FDA import refusal data for Dentsply Detrey 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.