NATURAL DENTAL LABORATORY CO LTD
⚠️ Moderate Risk
FEI: 3015134891 • Hong Kong • HONG KONG
FEI Number
3015134891
Location
Hong Kong
Country
HONG KONGAddress
Unit 04 7f Bright Way T, No 33 Mong Kok Rd Kl, 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
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).
Refusal History
Frequently Asked Questions
What is NATURAL DENTAL LABORATORY CO LTD's FDA import refusal history?
NATURAL DENTAL LABORATORY CO LTD (FEI: 3015134891) has 2 FDA import refusal record(s) in our database, spanning from 1/23/2025 to 1/23/2025.
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. NATURAL DENTAL LABORATORY CO LTD's FEI number is 3015134891.
What types of violations has NATURAL DENTAL LABORATORY CO LTD received?
NATURAL DENTAL LABORATORY CO LTD 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 NATURAL DENTAL LABORATORY CO LTD come from?
All FDA import refusal data for NATURAL DENTAL LABORATORY 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.