3shape Poland Sp
✅ Low Risk
FEI: 3009556636 • Szczecin, Zachodniopomorskie • POLAND
FEI Number
3009556636
Location
Szczecin, Zachodniopomorskie
Country
POLANDAddress
Ul. Zapadla 8, , Szczecin, Zachodniopomorskie, Poland
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2016 | 76NOFSYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) OF DENTAL RESTORATI | 476NO REGISTR | New York District Office (NYK-DO) |
| 6/19/2015 | 76KZNSCANNER, COLOR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/19/2014 | 76NOFSYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) OF DENTAL RESTORATI | 341REGISTERED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is 3shape Poland Sp's FDA import refusal history?
3shape Poland Sp (FEI: 3009556636) has 3 FDA import refusal record(s) in our database, spanning from 6/19/2014 to 1/7/2016.
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. 3shape Poland Sp's FEI number is 3009556636.
What types of violations has 3shape Poland Sp received?
3shape Poland Sp 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 3shape Poland Sp come from?
All FDA import refusal data for 3shape Poland Sp 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.