Data / Medical devices / United States / Danville Materials Research Center
Danville Materials Research Center: FDA-registered device maker in Anaheim, CA, United States, 18 510(k) clearances
Danville Materials Research Center is registered with the FDA (registration 3010664129) in Anaheim, CA, United States. It lists 10 device types. The FDA files 18 510(k) clearances under its listings, the newest dated September 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010664129
- Address
- 4020 E Leaverton Ct, Anaheim, CA, United States, 92807
- Owner or operator
- Zest Anchors, LLC (2023950)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 13, 2014
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Airbrush | KOJ | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Long-Term Temporary, Resin | POW | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Protector, Silicate | EFX | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2019 | K191619 | TurboTemp EZ | EBG | Substantially Equivalent | Zest Anchors, LLC | accessdata.fda.gov |
| August 28, 2015 | K151088 | DMRC Bulk Fill | EBF | Substantially Equivalent | Danville Materials, LLC | accessdata.fda.gov |
| June 16, 2014 | K140570 | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL | EBI | Substantially Equivalent | Zest Anchors, LLC | accessdata.fda.gov |
| September 25, 2012 | K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | EBF | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| September 21, 2011 | K111876 | Z BOND, PRELUDE ONE | KLE | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| May 27, 2011 | K110642 | SILJETR SYSTEM | EBF | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| February 4, 2011 | K102753 | TURBO TEMP 3 | EBG | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| December 16, 2009 | K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | EBF | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| September 16, 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | ELW | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| March 31, 2009 | K090106 | PRELUDE ONE | KLE | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| June 29, 2004 | K040952 | PRELUDE | KLE | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| May 3, 2002 | K020760 | STARFLOW HV | EBF | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| November 8, 2000 | K002502 | CERAM-PRIME | KLE | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| July 9, 1999 | K991450 | ETCHING GEL | EBF | Substantially Equivalent | Silicon-Und Composite Spezialitaten GmbH | accessdata.fda.gov |
| March 9, 1999 | K990108 | LC FLOWFILL | EBF | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| October 3, 1995 | K953504 | MICROPRIME | KLE | Substantially Equivalent | Danville Engineering, Inc. | accessdata.fda.gov |
| July 15, 1988 | K882576 | ACID ETCH GEL | EBF | Substantially Equivalent | Pulpdent Corp. of America | accessdata.fda.gov |
| July 6, 1979 | K790788 | FISSURE SEALER AND BONDING AGENT | EBC | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dam, Rubber
- All makers of Agent, Tooth Bonding, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Crown And Bridge, Long-Term Temporary, Resin
Updated September 11, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.