ZHUHAI MJ DIGITAL DENTAL STUDIO
⚠️ Moderate Risk
FEI: 3022087860 • Zhuhai, Guangdong • CHINA
FEI Number
3022087860
Location
Zhuhai, Guangdong
Country
CHINAAddress
No.3 6ty Road Pingxi, Nanping Technology Industrial Park Fl. 2ed, B3, Zhuhai, Guangdong, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 76NSKDENTURES, PARTIAL | Division of West Coast Imports (DWCI) | |
| 5/29/2025 | 76NSPRESTORATION, PORCELAIN | Division of West Coast Imports (DWCI) | |
| 5/15/2025 | 76NSORESTORATION, PORCELAIN-FUSED-TO-METAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is ZHUHAI MJ DIGITAL DENTAL STUDIO's FDA import refusal history?
ZHUHAI MJ DIGITAL DENTAL STUDIO (FEI: 3022087860) has 3 FDA import refusal record(s) in our database, spanning from 5/15/2025 to 5/29/2025.
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. ZHUHAI MJ DIGITAL DENTAL STUDIO's FEI number is 3022087860.
What types of violations has ZHUHAI MJ DIGITAL DENTAL STUDIO received?
ZHUHAI MJ DIGITAL DENTAL STUDIO 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 ZHUHAI MJ DIGITAL DENTAL STUDIO come from?
All FDA import refusal data for ZHUHAI MJ DIGITAL DENTAL STUDIO 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.