Tianjin Diadent Co., Ltd.
✅ Low Risk
FEI: 3004133229 • Tianjin City • CHINA
FEI Number
3004133229
Location
Tianjin City
Country
CHINAAddress
Jiazhuangzi Cun, Dasi Zhen,, Xiqing Qu, Tianjin City, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 |
|---|---|---|---|
| 4/18/2019 | 79FSMTRAY, SURGICAL, INSTRUMENT | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/10/2006 | 76EJLBUR, DENTAL | 341REGISTERED | Seattle District Office (SEA-DO) |
| 1/10/2006 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 341REGISTERED | Seattle District Office (SEA-DO) |
| 4/20/2005 | 76EKZUNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL | 341REGISTERED | Seattle District Office (SEA-DO) |
| 4/20/2005 | 76EKNPOINT, PAPER, ENDODONTIC | 341REGISTERED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Tianjin Diadent Co., Ltd.'s FDA import refusal history?
Tianjin Diadent Co., Ltd. (FEI: 3004133229) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 4/18/2019.
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. Tianjin Diadent Co., Ltd.'s FEI number is 3004133229.
What types of violations has Tianjin Diadent Co., Ltd. received?
Tianjin Diadent Co., Ltd. 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 Tianjin Diadent Co., Ltd. come from?
All FDA import refusal data for Tianjin Diadent 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.