Dentsply International Ceramco
⚠️ High Risk
FEI: 3012083920 • York, PA • UNITED STATES
FEI Number
3012083920
Location
York, PA
Country
UNITED STATESAddress
Shared Services Center, 470 W College Ave, York, PA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 12/8/2025 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 12/8/2025 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 1/18/2023 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 1/18/2023 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 76ELCSCALER, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 7/21/2021 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dentsply International Ceramco's FDA import refusal history?
Dentsply International Ceramco (FEI: 3012083920) has 6 FDA import refusal record(s) in our database, spanning from 7/21/2021 to 12/8/2025.
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 International Ceramco's FEI number is 3012083920.
What types of violations has Dentsply International Ceramco received?
Dentsply International Ceramco 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 International Ceramco come from?
All FDA import refusal data for Dentsply International Ceramco 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.