Orimar Dental Products Corp.
✅ Low Risk
FEI: 3003453896 • Miami, FL • UNITED STATES
FEI Number
3003453896
Location
Miami, FL
Country
UNITED STATESAddress
12305 Sw 132nd Ct, , Miami, FL, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
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
Frequently Asked Questions
What is Orimar Dental Products Corp.'s FDA import refusal history?
Orimar Dental Products Corp. (FEI: 3003453896) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2003 to 3/19/2003.
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. Orimar Dental Products Corp.'s FEI number is 3003453896.
What types of violations has Orimar Dental Products Corp. received?
Orimar Dental Products Corp. has been cited for 2 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 Orimar Dental Products Corp. come from?
All FDA import refusal data for Orimar Dental Products Corp. 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.