Dentsply Finance Co
⚠️ Moderate Risk
FEI: 3009094006 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3009094006
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 19b No 84, , Bogota, Cundinamarca, Colombia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2020 | 76EJBHANDLE, INSTRUMENT, DENTAL | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76DZCWIRE, ORTHODONTIC | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76KLEAGENT, TOOTH BONDING, RESIN | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76NSMRESTORATION, RESIN | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76NSMRESTORATION, RESIN | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 76NSMRESTORATION, RESIN | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dentsply Finance Co's FDA import refusal history?
Dentsply Finance Co (FEI: 3009094006) has 7 FDA import refusal record(s) in our database, spanning from 8/22/2020 to 8/22/2020.
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 Finance Co's FEI number is 3009094006.
What types of violations has Dentsply Finance Co received?
Dentsply Finance Co 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 Finance Co come from?
All FDA import refusal data for Dentsply Finance Co 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.