Danville Materials, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Danville Materials, Inc.” (first 2001, latest 2012), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 | 1 | 89 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| ELR | Post, Root Canal | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
Review panels
- Dental (11)
Most recent Danville Materials, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | EBF | 2012-09-25 | 89 |
| K111876 | Z BOND, PRELUDE ONE | KLE | 2011-09-21 | 82 |
| K110642 | SILJETR SYSTEM | EBF | 2011-05-27 | 81 |
| K102753 | TURBO TEMP 3 | EBG | 2011-02-04 | 134 |
| K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | EBF | 2009-12-16 | 85 |
| K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | ELW | 2009-09-16 | 43 |
| K090106 | PRELUDE ONE | KLE | 2009-03-31 | 89 |
| K040952 | PRELUDE | KLE | 2004-06-29 | 78 |
| K033215 | PREPAIR | KOJ | 2004-01-09 | 98 |
| K020760 | STARFLOW HV | EBF | 2002-05-03 | 57 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-06-24.
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.
- Danville Materials, LLC (5 510(k)s)
- Danville Engineering, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Danville Materials, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Danville Materials, Inc.” (first 2001, latest 2012), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Danville Materials, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Danville Materials, Inc. is 82 days.
Which FDA product codes appear under Danville Materials, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 4); KLE (Agent, Tooth Bonding, Resin, 3); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 11 Danville Materials, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Danville Materials, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.