Den-Mat Holdings, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Den-Mat Holdings, LLC” (first 2008, latest 2024), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 121 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 169 |
| 2015 | 1 | 128 |
| 2016 | 0 | — |
| 2017 | 1 | 151 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 89 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Den-Mat Holdings, LLC took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| NXV | Diagnostic Light, Soft Tissue Detector | 1 | 1 |
Review panels
Most recent Den-Mat Holdings, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242097 | DenMat Bulk Fill Composite | EBF | 2024-10-15 | 89 |
| K162967 | nuance UNIVERSAL | EBF | 2017-03-24 | 151 |
| K143679 | Nuance FLOW | EBF | 2015-05-01 | 128 |
| K140537 | TENURE4G | KLE | 2014-08-20 | 169 |
| K110079 | SPPHINE PLUS STM 3W DIODE LASER | GEX | 2011-02-10 | 30 |
| K103667 | SAPPHIRE ST PORTABLE DIODE LASER | GEX | 2010-12-29 | 14 |
| K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | EBZ | 2008-11-21 | 198 |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | NXV | 2008-04-03 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Den-Mat Holdings, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Den-Mat Corp. (29 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Den-Mat Holdings, LLC?
FDA lists 8 510(k) clearances under the applicant name “Den-Mat Holdings, LLC” (first 2008, latest 2024), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Den-Mat Holdings, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Den-Mat Holdings, LLC is 121 days.
Which FDA product codes appear under Den-Mat Holdings, LLC?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); GEX (Powered Laser Surgical Instrument, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1).
Next steps
- See all 8 Den-Mat Holdings, LLC clearances with predicates and recalls
- Run predicate analysis for product code EBF, Den-Mat Holdings, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.