Danville Materials, Inc.
San Ramon, CA, US
Danville Materials, Inc. appears in FDA device records in San Ramon, CA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Danville Materials, Inc. between 2001 and 2015. The busiest year on record is 2015, with 5. The most recent is 2015, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2009 | 3 |
| 2011 | 3 |
| 2012 | 1 |
| 2015 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152349 | Star+ VPS Scannable Impression Material | ELW | Substantially Equivalent | |
| K151514 | Prestige | EBF | Substantially Equivalent | |
| K151088 | DMRC Bulk Fill | EBF | Substantially Equivalent | |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | DYH | Substantially Equivalent | |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | DYH | Substantially Equivalent | |
| K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | EBF | Substantially Equivalent | |
| K111876 | Z BOND, PRELUDE ONE | KLE | Substantially Equivalent | |
| K110642 | SILJETR SYSTEM | EBF | Substantially Equivalent | |
| K102753 | TURBO TEMP 3 | EBG | Substantially Equivalent | |
| K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | EBF | Substantially Equivalent | |
| K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | ELW | Substantially Equivalent | |
| K090106 | PRELUDE ONE | KLE | Substantially Equivalent | |
| K040952 | PRELUDE | KLE | Substantially Equivalent | |
| K033215 | PREPAIR | KOJ | Substantially Equivalent | |
| K020760 | STARFLOW HV | EBF | Substantially Equivalent | |
| K012354 | SNOWPOST, SNOWLIGHT | ELR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2530-2016 | Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay). | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain