Dentsply Detrey
⚠️ Moderate Risk
FEI: 3004971064 • Radolfzell Am Bodensee, Baden-Wurttemberg • GERMANY
FEI Number
3004971064
Location
Radolfzell Am Bodensee, Baden-Wurttemberg
Country
GERMANYAddress
Guttinger Str. 35, , Radolfzell Am Bodensee, Baden-Wurttemberg, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2013 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | San Juan District Office (SJN-DO) |
| 10/10/2008 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76EMACEMENT, DENTAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76EMACEMENT, DENTAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76KIFRESIN, ROOT CANAL FILLING | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76EMACEMENT, DENTAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76LBHVARNISH, CAVITY | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/10/2008 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Dentsply Detrey's FDA import refusal history?
Dentsply Detrey (FEI: 3004971064) has 11 FDA import refusal record(s) in our database, spanning from 10/10/2008 to 8/20/2013.
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 3004971064.
What types of violations has Dentsply Detrey received?
Dentsply Detrey 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 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.