SYBRON DENTAL
⚠️ Moderate Risk
FEI: 3014485933 • Villa Uman, Yucatan • MEXICO
FEI Number
3014485933
Location
Villa Uman, Yucatan
Country
MEXICOAddress
Ormex S. De R.L. De C. V., Ampliacion Ciuda; Calle 21 Num 1103; Uman, Villa Uman, Yucatan, Mexico
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2025 | 76ELCSCALER, ULTRASONIC | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SYBRON DENTAL's FDA import refusal history?
SYBRON DENTAL (FEI: 3014485933) has 1 FDA import refusal record(s) in our database, spanning from 4/22/2025 to 4/22/2025.
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. SYBRON DENTAL's FEI number is 3014485933.
What types of violations has SYBRON DENTAL received?
SYBRON DENTAL has been cited for 1 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 SYBRON DENTAL come from?
All FDA import refusal data for SYBRON 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.