SKY ORTHO DENTAL SUPPLY COMPANY LTD.
✅ Low Risk
FEI: 3006853931 • Yancheng, Jiangsu • CHINA
FEI Number
3006853931
Location
Yancheng, Jiangsu
Country
CHINAAddress
No 7 Yan Ma Road, , Yancheng, Jiangsu, 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
Frequently Asked Questions
What is SKY ORTHO DENTAL SUPPLY COMPANY LTD.'s FDA import refusal history?
SKY ORTHO DENTAL SUPPLY COMPANY LTD. (FEI: 3006853931) has 3 FDA import refusal record(s) in our database, spanning from 1/10/2014 to 5/5/2014.
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. SKY ORTHO DENTAL SUPPLY COMPANY LTD.'s FEI number is 3006853931.
What types of violations has SKY ORTHO DENTAL SUPPLY COMPANY LTD. received?
SKY ORTHO DENTAL SUPPLY COMPANY 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 SKY ORTHO DENTAL SUPPLY COMPANY LTD. come from?
All FDA import refusal data for SKY ORTHO DENTAL SUPPLY COMPANY 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.