Dentsply Caulk
⚠️ High Risk
FEI: 2515379 • Milford, DE • UNITED STATES
FEI Number
2515379
Location
Milford, DE
Country
UNITED STATESAddress
38 W Clarke Ave, , Milford, DE, 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
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.
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).
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northeast Imports (DNEI) | |
| 4/25/2025 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | Division of Northern Border Imports (DNBI) | |
| 1/7/2025 | 76ELWMATERIAL, IMPRESSION | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 1/7/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 1/7/2025 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 1/7/2025 | 76EMACEMENT, DENTAL | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 1/7/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 1/7/2025 | 76KLEAGENT, TOOTH BONDING, RESIN | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/26/2024 | 76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/26/2024 | 76EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/14/2024 | 76ELWMATERIAL, IMPRESSION | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/14/2024 | 76ELWMATERIAL, IMPRESSION | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/14/2024 | 76ELWMATERIAL, IMPRESSION | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/14/2024 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/14/2024 | 76EMACEMENT, DENTAL | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 2/12/2021 | 76EMACEMENT, DENTAL | Division of Southeast Imports (DSEI) | |
| 2/12/2021 | 76ELWMATERIAL, IMPRESSION | Division of Southeast Imports (DSEI) | |
| 9/15/2017 | 76EBGCROWN AND BRIDGE, TEMPORARY, RESIN | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76ELWMATERIAL, IMPRESSION | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EMNSCALER, PERIODONTIC | Division of Northern Border Imports (DNBI) | |
| 9/15/2017 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | Division of Northern Border Imports (DNBI) | |
| 4/19/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 4/19/2012 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 4/19/2012 | 76EMACEMENT, DENTAL | New York District Office (NYK-DO) | |
| 4/7/2011 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | New York District Office (NYK-DO) | |
| 4/7/2011 | 76KLEAGENT, TOOTH BONDING, RESIN | New York District Office (NYK-DO) | |
| 4/7/2011 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 1/11/2011 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/11/2011 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/17/2004 | 76EJBHANDLE, INSTRUMENT, DENTAL | 479DV QUALITY | New York District Office (NYK-DO) |
| 9/17/2004 | 76EJBHANDLE, INSTRUMENT, DENTAL | 479DV QUALITY | New York District Office (NYK-DO) |
| 9/17/2004 | 76EJBHANDLE, INSTRUMENT, DENTAL | 479DV QUALITY | New York District Office (NYK-DO) |
| 7/27/2004 | 60QDY99ANESTHETIC, N.E.C. | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dentsply Caulk's FDA import refusal history?
Dentsply Caulk (FEI: 2515379) has 35 FDA import refusal record(s) in our database, spanning from 7/27/2004 to 10/24/2025.
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 Caulk's FEI number is 2515379.
What types of violations has Dentsply Caulk received?
Dentsply Caulk has been cited for 5 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 Caulk come from?
All FDA import refusal data for Dentsply Caulk 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.