Onsite Dental
⚠️ Moderate Risk
FEI: 3007135630 • San Carlos, CA • UNITED STATES
FEI Number
3007135630
Location
San Carlos, CA
Country
UNITED STATESAddress
1050 Commercial St, , San Carlos, 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
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 |
|---|---|---|---|
| 10/10/2008 | 90MUHSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL | New Orleans District Office (NOL-DO) | |
| 10/10/2008 | 76EBALIGHT, SURGICAL HEADLIGHT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/10/2008 | 76KLCCHAIR WITH UNIT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/10/2008 | 76KLCCHAIR WITH UNIT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Onsite Dental's FDA import refusal history?
Onsite Dental (FEI: 3007135630) has 4 FDA import refusal record(s) in our database, spanning from 10/10/2008 to 10/10/2008.
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. Onsite Dental's FEI number is 3007135630.
What types of violations has Onsite Dental received?
Onsite Dental has been cited for 3 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 Onsite Dental come from?
All FDA import refusal data for Onsite Dental 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.