Modern Dental Global Solutions Limited
⚠️ Moderate Risk
FEI: 3015674959 • Cheung Sha Wan, Kowloon • HONG KONG
FEI Number
3015674959
Location
Cheung Sha Wan, Kowloon
Country
HONG KONGAddress
Room 1701, 07, 09-16 Ceo Tower, 77 Wing; Hong Street, Cheung Sha Wan, Kowloon, Hong Kong
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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Modern Dental Global Solutions Limited's FDA import refusal history?
Modern Dental Global Solutions Limited (FEI: 3015674959) has 1 FDA import refusal record(s) in our database, spanning from 12/3/2013 to 12/3/2013.
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. Modern Dental Global Solutions Limited's FEI number is 3015674959.
What types of violations has Modern Dental Global Solutions Limited received?
Modern Dental Global Solutions Limited 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 Modern Dental Global Solutions Limited come from?
All FDA import refusal data for Modern Dental Global Solutions Limited 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.