Dentsply Sirona Preventive
⚠️ Moderate Risk
FEI: 3002088145 • York, PA • UNITED STATES
FEI Number
3002088145
Location
York, PA
Country
UNITED STATESAddress
1301 Smile Way, , York, PA, United States
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
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.
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 |
|---|---|---|---|
| 1/27/2023 | 76EIHPOWDER, PORCELAIN | Division of Southeast Imports (DSEI) | |
| 3/10/2022 | 76ELCSCALER, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 2/12/2021 | 76EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY | Division of Southeast Imports (DSEI) | |
| 2/12/2021 | 76DZNMATRIX, DENTAL | Division of Southeast Imports (DSEI) | |
| 9/15/2017 | 76EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING | Division of Northern Border Imports (DNBI) | |
| 4/7/2016 | 76EIHPOWDER, PORCELAIN | Seattle District Office (SEA-DO) | |
| 1/21/2016 | 76EIHPOWDER, PORCELAIN | 2780DEVICEGMPS | Seattle District Office (SEA-DO) |
| 2/4/2015 | 76ELWMATERIAL, IMPRESSION | New York District Office (NYK-DO) | |
| 11/25/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 7/11/2013 | 76DZNMATRIX, DENTAL | 341REGISTERED | New York District Office (NYK-DO) |
| 12/20/2011 | 63RCJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/8/2010 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dentsply Sirona Preventive's FDA import refusal history?
Dentsply Sirona Preventive (FEI: 3002088145) has 12 FDA import refusal record(s) in our database, spanning from 12/8/2010 to 1/27/2023.
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. Dentsply Sirona Preventive's FEI number is 3002088145.
What types of violations has Dentsply Sirona Preventive received?
Dentsply Sirona Preventive has been cited for 6 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 Sirona Preventive come from?
All FDA import refusal data for Dentsply Sirona Preventive 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.