DENTSPLY Implants (a Division of DENTSPLY IH AB)
⚠️ Moderate Risk
FEI: 3002806429 • Molndal, Vastra Gotalands Lan • SWEDEN
FEI Number
3002806429
Location
Molndal, Vastra Gotalands Lan
Country
SWEDENAddress
Aminogatan 1, , Molndal, Vastra Gotalands Lan, Sweden
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2016 | 79OVNSUTURE KIT | 118NOT LISTED | Detroit District Office (DET-DO) |
| 11/13/2014 | 76DZEIMPLANT, ENDOSSEOUS | Detroit District Office (DET-DO) | |
| 11/13/2014 | 76DZEIMPLANT, ENDOSSEOUS | Detroit District Office (DET-DO) | |
| 11/13/2014 | 76DZEIMPLANT, ENDOSSEOUS | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is DENTSPLY Implants (a Division of DENTSPLY IH AB)'s FDA import refusal history?
DENTSPLY Implants (a Division of DENTSPLY IH AB) (FEI: 3002806429) has 4 FDA import refusal record(s) in our database, spanning from 11/13/2014 to 6/22/2016.
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. DENTSPLY Implants (a Division of DENTSPLY IH AB)'s FEI number is 3002806429.
What types of violations has DENTSPLY Implants (a Division of DENTSPLY IH AB) received?
DENTSPLY Implants (a Division of DENTSPLY IH AB) 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 DENTSPLY Implants (a Division of DENTSPLY IH AB) come from?
All FDA import refusal data for DENTSPLY Implants (a Division of DENTSPLY IH AB) 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.