Andent Dental Co Ltd
✅ Low Risk
FEI: 3012042263 • Huanghua • CHINA
FEI Number
3012042263
Location
Huanghua
Country
CHINAAddress
Mould Industry District, , Huanghua, , China
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
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 |
|---|---|---|---|
| 10/28/2019 | 79FSMTRAY, SURGICAL, INSTRUMENT | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Andent Dental Co Ltd's FDA import refusal history?
Andent Dental Co Ltd (FEI: 3012042263) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2019 to 10/28/2019.
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. Andent Dental Co Ltd's FEI number is 3012042263.
What types of violations has Andent Dental Co Ltd received?
Andent Dental Co 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 Andent Dental Co Ltd come from?
All FDA import refusal data for Andent Dental Co 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.