Den-Mat Holdings, LLC
FDA Regulatory Profile
Den-Mat Holdings, LLC appears in FDA public data with 2 recalls, 8 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0287-2024, Class II) was initiated on January 16, 2024. Its most recent 510(k) clearance was granted on October 15, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 8
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0287-2024 | Class II | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 | January 16, 2024 |
| D-0286-2024 | Class II | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, | January 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242097 | DenMat Bulk Fill Composite | October 15, 2024 |
| K162967 | nuance UNIVERSAL | March 24, 2017 |
| K143679 | Nuance FLOW | May 1, 2015 |
| K140537 | TENURE4G | August 20, 2014 |
| K110079 | SPPHINE PLUS STM 3W DIODE LASER | February 10, 2011 |
| K103667 | SAPPHIRE ST PORTABLE DIODE LASER | December 29, 2010 |
| K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | November 21, 2008 |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | April 3, 2008 |