Nobel Biocare Usa Llc
⚠️ Moderate Risk
FEI: 1000125598 • Pomona, CA • UNITED STATES
FEI Number
1000125598
Location
Pomona, CA
Country
UNITED STATESAddress
1889 W Mission Blvd, , Pomona, CA, United States
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
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 |
|---|---|---|---|
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 77ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76DZEIMPLANT, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76EMACEMENT, DENTAL | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/20/2005 | 76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Nobel Biocare Usa Llc's FDA import refusal history?
Nobel Biocare Usa Llc (FEI: 1000125598) has 11 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 4/20/2005.
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 Usa Llc's FEI number is 1000125598.
What types of violations has Nobel Biocare Usa Llc received?
Nobel Biocare Usa Llc 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 Usa Llc come from?
All FDA import refusal data for Nobel Biocare Usa Llc 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.