Odontobras
⚠️ Moderate Risk
FEI: 3003629500 • Ribeirao Preto, Sao Paulo • BRAZIL
FEI Number
3003629500
Location
Ribeirao Preto, Sao Paulo
Country
BRAZILAddress
Rua Santos 1275, , Ribeirao Preto, Sao Paulo, Brazil
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).
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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 |
|---|---|---|---|
| 1/21/2004 | 76ECFSTERILIZER, DRY HEAT, ENDODONTIC | 2380NO PMA/PDP | Division of Southeast Imports (DSEI) |
| 7/15/2003 | 76ECFSTERILIZER, DRY HEAT, ENDODONTIC | Florida District Office (FLA-DO) | |
| 8/7/2002 | 80KMHSTERILIZER, DRY HEAT | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Odontobras's FDA import refusal history?
Odontobras (FEI: 3003629500) has 3 FDA import refusal record(s) in our database, spanning from 8/7/2002 to 1/21/2004.
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. Odontobras's FEI number is 3003629500.
What types of violations has Odontobras received?
Odontobras has been cited for 4 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 Odontobras come from?
All FDA import refusal data for Odontobras 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.