Royal Dental Laboratory
⚠️ Moderate Risk
FEI: 3004086183 • Shenzhen • CHINA
FEI Number
3004086183
Location
Shenzhen
Country
CHINAAddress
Shangxue Science & Technology Industry P, Block 2nd ; NO. 4 West Region, Shenzhen, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2017 | 76ELZCROWN, PREFORMED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/22/2017 | 76ELZCROWN, PREFORMED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/20/2017 | 76ELZCROWN, PREFORMED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/23/2011 | 76NSLDENTURES, FULL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/23/2011 | 76NSORESTORATION, PORCELAIN-FUSED-TO-METAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Royal Dental Laboratory's FDA import refusal history?
Royal Dental Laboratory (FEI: 3004086183) has 5 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 11/29/2017.
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. Royal Dental Laboratory's FEI number is 3004086183.
What types of violations has Royal Dental Laboratory received?
Royal Dental Laboratory 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 Royal Dental Laboratory come from?
All FDA import refusal data for Royal Dental Laboratory 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.