Premier Dental Products Co
⚠️ Moderate Risk
FEI: 2511556 • Plymouth Meeting, PA • UNITED STATES
FEI Number
2511556
Location
Plymouth Meeting, PA
Country
UNITED STATESAddress
1710 Romano Dr, , Plymouth Meeting, PA, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2024 | 76MVLCORD, RETRACTION | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/4/2023 | 76EMACEMENT, DENTAL | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 8/4/2023 | 76EBFMATERIAL, TOOTH SHADE, RESIN | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 3/16/2022 | 76EKQPREPARER, ROOT CANAL ENDODONTIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/16/2022 | 76MVLCORD, RETRACTION | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/16/2022 | 76EMACEMENT, DENTAL | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/16/2022 | 76MVLCORD, RETRACTION | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/16/2022 | 76EKQPREPARER, ROOT CANAL ENDODONTIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 10/5/2011 | 76EKJBURNISHER, OPERATIVE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/5/2011 | 76EMNSCALER, PERIODONTIC | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/1/2010 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 4/1/2010 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 4/1/2010 | 76EJBHANDLE, INSTRUMENT, DENTAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Premier Dental Products Co's FDA import refusal history?
Premier Dental Products Co (FEI: 2511556) has 13 FDA import refusal record(s) in our database, spanning from 4/1/2010 to 8/19/2024.
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. Premier Dental Products Co's FEI number is 2511556.
What types of violations has Premier Dental Products Co received?
Premier Dental Products Co 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 Premier Dental Products Co come from?
All FDA import refusal data for Premier Dental Products Co 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.