Nobel Biocare
⚠️ Moderate Risk
FEI: 3002670292 • The Netherlands • NETHERLANDS
FEI
FEI Number
3002670292
📍
Location
The Netherlands
🇳🇱
Country
NETHERLANDS🏢
Address
Bolderweg 301332 Ave Almere, , The Netherlands, , Netherlands
Moderate Risk
FDA Import Risk Assessment
49.7
LowModerateHighCritical
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
134
Total Refusals
2
Unique Violations
6/30/2008
Latest Refusal
6/30/2008
Earliest Refusal
Score Breakdown
Violation Severity
40.0×40%
Refusal Volume
78.9×30%
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
118134×
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).
341134×
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 |
|---|---|---|---|
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76ECTDRIVER, BAND, ORTHODONTIC | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76ECTDRIVER, BAND, ORTHODONTIC | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Los Angeles District Office (LOS-DO) | |
| 6/30/2008 | 76DZADRILL, DENTAL, INTRAORAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Nobel Biocare's FDA import refusal history?
Nobel Biocare (FEI: 3002670292) has 134 FDA import refusal record(s) in our database, spanning from 6/30/2008 to 6/30/2008.
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. Nobel Biocare's FEI number is 3002670292.
What types of violations has Nobel Biocare received?
Nobel Biocare 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 Nobel Biocare come from?
All FDA import refusal data for Nobel Biocare 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.