Dentech Corp.
⚠️ Moderate Risk
FEI: 3002809535 • Itabashi, Tokyo • JAPAN
FEI
FEI Number
3002809535
📍
Location
Itabashi, Tokyo
🇯🇵
Country
JAPAN🏢
Address
53, Shimizu-Cho, Itabashi, Tokyo, Japan
Moderate Risk
FDA Import Risk Assessment
41.9
LowModerateHighCritical
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
61
Total Refusals
1
Unique Violations
5/14/2019
Latest Refusal
5/14/2019
Earliest Refusal
Score Breakdown
Violation Severity
30.0×40%
Refusal Volume
66.4×30%
Recency
0.0×20%
Frequency
100.0×10%
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
34161×
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/14/2019 | 76EEFCLAMP, RUBBER DAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dentech Corp.'s FDA import refusal history?
Dentech Corp. (FEI: 3002809535) has 61 FDA import refusal record(s) in our database, spanning from 5/14/2019 to 5/14/2019.
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. Dentech Corp.'s FEI number is 3002809535.
What types of violations has Dentech Corp. received?
Dentech Corp. 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 Dentech Corp. come from?
All FDA import refusal data for Dentech Corp. 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.