Co-Re-Na Ecza Deposu Dis Tic.L
⚠️ Moderate Risk
FEI: 3006720807 • Ankara • TURKEY
FEI Number
3006720807
Location
Ankara
Country
TURKEYAddress
469. Sokak Toyko Villalari No:, , Ankara, , Turkey
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
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 |
|---|---|---|---|
| 1/12/2009 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 1/12/2009 | 76EMACEMENT, DENTAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 1/12/2009 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 1/12/2009 | 76EIHPOWDER, PORCELAIN | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 1/12/2009 | 76KOPADHESIVE, DENTURE, KARAYA | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 1/12/2009 | 76ELZCROWN, PREFORMED | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Co-Re-Na Ecza Deposu Dis Tic.L's FDA import refusal history?
Co-Re-Na Ecza Deposu Dis Tic.L (FEI: 3006720807) has 6 FDA import refusal record(s) in our database, spanning from 1/12/2009 to 1/12/2009.
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. Co-Re-Na Ecza Deposu Dis Tic.L's FEI number is 3006720807.
What types of violations has Co-Re-Na Ecza Deposu Dis Tic.L received?
Co-Re-Na Ecza Deposu Dis Tic.L has been cited for 1 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 Co-Re-Na Ecza Deposu Dis Tic.L come from?
All FDA import refusal data for Co-Re-Na Ecza Deposu Dis Tic.L 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.