Denjoy Dental Co Ltd
⚠️ Moderate Risk
FEI: 3008590661 • Changsha, Hunan • CHINA
FEI Number
3008590661
Location
Changsha, Hunan
Country
CHINAAddress
Bldg A4 F 4, NO. 229 Guyuan Road, Changsha, Hunan, China
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2016 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | Seattle District Office (SEA-DO) | |
| 9/15/2016 | 79FTSCAMERA, CINE, ENDOSCOPIC, WITH AUDIO | Seattle District Office (SEA-DO) | |
| 7/11/2016 | 80KYTLIGHT, EXAMINATION, MEDICAL, BATTERY POWERED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Denjoy Dental Co Ltd's FDA import refusal history?
Denjoy Dental Co Ltd (FEI: 3008590661) has 3 FDA import refusal record(s) in our database, spanning from 7/11/2016 to 9/15/2016.
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. Denjoy Dental Co Ltd's FEI number is 3008590661.
What types of violations has Denjoy Dental Co Ltd received?
Denjoy Dental Co Ltd has been cited for 4 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 Denjoy Dental Co Ltd come from?
All FDA import refusal data for Denjoy 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.