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Data / Medical devices / Material, Impression / United States

FDA-registered makers of Material, Impression in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Material, Impression (product code ELW). 24 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device
Material, Impression
Product code
ELW
Country
United States

Makers of Material, Impression in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Dentsply LLCMilford, DE, United StatesManufacturer, Specification developer15March 4, 2016000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler14July 12, 2018000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler12April 27, 2023010api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler11December 8, 2010010api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer10May 30, 2013000api.fda.gov
Ivoclar Vivadent, Inc.Amherst, NY, United StatesRepackager or relabeler, Specification developer6April 3, 2015010api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6June 30, 2016010api.fda.gov
Crown Delta Corp.Yorktown, NY, United StatesContract manufacturer, Manufacturer, Repackager or relabeler5May 14, 2004000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer, Repackager or relabeler4May 14, 2004000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesRepackager or relabeler, Specification developer3May 27, 2016000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer3February 25, 1994000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer3October 31, 1996000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer3October 31, 1996000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer3October 31, 1996000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer3February 12, 1998000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer3November 23, 2015000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer, Repackager or relabeler2September 6, 1996000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor1August 8, 2022000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer1September 16, 2009000api.fda.gov
IPB IncOgden, UT, United StatesManufacturer1July 28, 2015000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesSpecification developer1February 25, 1997000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler1February 25, 1994000api.fda.gov
Sonrisa/Easy Denture/NSIWilmington, NC, United StatesSpecification developer1January 19, 2023000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer1April 14, 1981000api.fda.gov

Updated November 2, 2026. 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.