Gladent International Co Limited
⚠️ Moderate Risk
FEI: 3009051155 • Hong Kong • HONG KONG
FEI Number
3009051155
Location
Hong Kong
Country
HONG KONGAddress
Flat Rm 1202 12f Chun Comm Ctrshanghai, , Hong Kong, , 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).
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2013 | 76EFBHANDPIECE, AIR-POWERED, DENTAL | Seattle District Office (SEA-DO) | |
| 9/12/2011 | 76EJLBUR, DENTAL | New York District Office (NYK-DO) | |
| 9/12/2011 | 76EFDAMALGAMATOR, DENTAL, AC-POWERED | New York District Office (NYK-DO) | |
| 9/12/2011 | 76LQYLOCATOR, ROOT APEX | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Gladent International Co Limited's FDA import refusal history?
Gladent International Co Limited (FEI: 3009051155) has 4 FDA import refusal record(s) in our database, spanning from 9/12/2011 to 7/30/2013.
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. Gladent International Co Limited's FEI number is 3009051155.
What types of violations has Gladent International Co Limited received?
Gladent International Co Limited has been cited for 5 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 Gladent International Co Limited come from?
All FDA import refusal data for Gladent International Co 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.