Dentsply Industria Comercio Ltda
⚠️ Moderate Risk
FEI: 1000166986 • Petropolis, Rio De Janeiro • BRAZIL
FEI Number
1000166986
Location
Petropolis, Rio De Janeiro
Country
BRAZILAddress
R Alice Herve 86, , Petropolis, Rio De Janeiro, Brazil
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2016 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | Florida District Office (FLA-DO) | |
| 1/23/2015 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | Florida District Office (FLA-DO) | |
| 1/23/2015 | 76EMACEMENT, DENTAL | Florida District Office (FLA-DO) | |
| 1/23/2015 | 76KLEAGENT, TOOTH BONDING, RESIN | Florida District Office (FLA-DO) | |
| 12/24/2013 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | New Orleans District Office (NOL-DO) | |
| 12/24/2013 | 76EHMSTRIP, POLISHING AGENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/31/2012 | 76ELWMATERIAL, IMPRESSION | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Dentsply Industria Comercio Ltda's FDA import refusal history?
Dentsply Industria Comercio Ltda (FEI: 1000166986) has 7 FDA import refusal record(s) in our database, spanning from 8/31/2012 to 3/8/2016.
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 Industria Comercio Ltda's FEI number is 1000166986.
What types of violations has Dentsply Industria Comercio Ltda received?
Dentsply Industria Comercio Ltda 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 Industria Comercio Ltda come from?
All FDA import refusal data for Dentsply Industria Comercio Ltda 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.