DENTCARE DENTAL LAB PVT. LTD.
⚠️ Moderate Risk
FEI: 3011195066 • Velloorkunnam, Kerala • INDIA
FEI Number
3011195066
Location
Velloorkunnam, Kerala
Country
INDIAAddress
130 Naz Road, , Velloorkunnam, Kerala, India
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 |
|---|---|---|---|
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DENTCARE DENTAL LAB PVT. LTD.'s FDA import refusal history?
DENTCARE DENTAL LAB PVT. LTD. (FEI: 3011195066) has 8 FDA import refusal record(s) in our database, spanning from 5/14/2025 to 5/14/2025.
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. DENTCARE DENTAL LAB PVT. LTD.'s FEI number is 3011195066.
What types of violations has DENTCARE DENTAL LAB PVT. LTD. received?
DENTCARE DENTAL LAB PVT. LTD. 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 DENTCARE DENTAL LAB PVT. LTD. come from?
All FDA import refusal data for DENTCARE DENTAL LAB PVT. LTD. 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.