Ormco/Sybronendo
⚠️ Moderate Risk
FEI: 2016150 • Glendora, CA • UNITED STATES
FEI Number
2016150
Location
Glendora, CA
Country
UNITED STATESAddress
1332 S Lone Hill Ave, , Glendora, 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).
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).
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.
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 |
|---|---|---|---|
| 9/15/2017 | 76KIFRESIN, ROOT CANAL FILLING | Division of Northern Border Imports (DNBI) | |
| 5/20/2015 | 76EATTESTER, PULP | New York District Office (NYK-DO) | |
| 1/5/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 1/5/2015 | 76EBFMATERIAL, TOOTH SHADE, RESIN | New York District Office (NYK-DO) | |
| 12/10/2014 | 76EKSFILE, PULP CANAL, ENDODONTIC | New York District Office (NYK-DO) | |
| 9/22/2014 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Northeast Imports (DNEI) | |
| 9/22/2014 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Northeast Imports (DNEI) | |
| 12/12/2011 | 76EJFBRACKET, METAL, ORTHODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 76EJFBRACKET, METAL, ORTHODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 76EJFBRACKET, METAL, ORTHODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 76EJFBRACKET, METAL, ORTHODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/10/2010 | 76NPKBARRIER, SYNTHETIC, DENTAL | Detroit District Office (DET-DO) | |
| 9/23/2010 | 76EKSFILE, PULP CANAL, ENDODONTIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/23/2010 | 76EKMGUTTA-PERCHA | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/7/2006 | 76DYWBRACKET, PLASTIC, ORTHODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ormco/Sybronendo's FDA import refusal history?
Ormco/Sybronendo (FEI: 2016150) has 15 FDA import refusal record(s) in our database, spanning from 12/7/2006 to 9/15/2017.
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. Ormco/Sybronendo's FEI number is 2016150.
What types of violations has Ormco/Sybronendo received?
Ormco/Sybronendo 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 Ormco/Sybronendo come from?
All FDA import refusal data for Ormco/Sybronendo 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.