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Data / Medical devices / Material, Impression

Material, Impression (ELW): 82 FDA-registered makers in 17 countries

82 establishments in 17 countries are registered with the FDA to make Material, Impression (product code ELW, Class 2, 21 CFR 872.3660). 76 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 404 510(k) clearances under this code, the latest on September 16, 2026, and lists 8 recall events (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
ELW
Device class
2
Regulation
872.3660
Medical specialty
Dental

Makers by country

CountryMakers
United States24
Germany14
South Korea13
China6
Italy5
Japan4
Mexico3
India3
Switzerland2
Netherlands1
Czechia1
Greece1
Belgium1
Turkey1
United Kingdom1
Brazil1
Romania1

Makers of Material, Impression

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Solventum Germany GmbHSEEFELD Bavaria, GermanyComplaint file establishment, Manufacturer23February 1, 2022000api.fda.gov
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
Zhermack S.P.A.BADIA POLESINE (RO) Rovigo, ItalyContract manufacturer, Manufacturer14March 26, 2009000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler12April 27, 2023010api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Specification developer12May 17, 2013000api.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
Cavex Holland B.V.HAARLEM Noord-Holland, NetherlandsContract manufacturer, Manufacturer8October 28, 2015000api.fda.gov
Coltene/Whaledent AGALTSTAETTEN Sankt Gallen, SwitzerlandManufacturer7January 13, 2022000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer7July 12, 2018000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyManufacturer7May 30, 2013000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer6May 10, 2012000api.fda.gov
Ivoclar Vivadent, Inc.Amherst, NY, United StatesRepackager or relabeler, Specification developer6April 3, 2015010api.fda.gov
Kettenbach GMBH & Co KGESCHENBURG Hesse, GermanyManufacturer6October 1, 2009000api.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
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer5November 3, 2016000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer4October 22, 2001000api.fda.gov
Hygedent Inc.Beijing, ChinaContract manufacturer, Exporter to the US, Manufacturer4April 19, 2021000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer, Repackager or relabeler4May 14, 2004000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer4March 18, 2021000api.fda.gov
Osstem Implant Co., Ltd.SIHEUNG Gyeonggi, South KoreaManufacturer4March 18, 2021000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesRepackager or relabeler, Specification developer3May 27, 2016000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer3June 27, 2025000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer3February 25, 1994000api.fda.gov
Diadent Group InternationalCHONGJU CITY Chungbuk, South KoreaManufacturer3September 16, 2026000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer, Repackager or relabeler3July 12, 2018000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer, Repackager or relabeler3November 1, 2001000api.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
SpofaDental a.s.Jicin, CzechiaContract manufacturer, Manufacturer3August 5, 2016000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer3February 12, 1998000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer, Repackager or relabeler3March 28, 2011000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer3November 23, 2015000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer2November 7, 2019000api.fda.gov
Handae Chemical Co., LtdJincheon-gun Chungbuk, South KoreaManufacturer, Repackager or relabeler2August 15, 2014000api.fda.gov
HRS Co., Ltd.Pyongtaek Gyeonggi, South KoreaManufacturer2November 28, 2018000api.fda.gov
La.sc.od. SPAFLORENCE, TUSCANY Firenze, ItalyManufacturer2May 5, 2020000api.fda.gov
Ormex S. de R.L. de C.V.Yucatan Uman, MexicoContract manufacturer, Manufacturer2March 11, 1996000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer, Repackager or relabeler2September 6, 1996000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer2September 24, 2020000api.fda.gov
B&e Korea Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer1February 13, 2024000api.fda.gov
Chemoment Materials Co.,ltdHefei Anhui, ChinaExporter to the US, Manufacturer1August 8, 2022000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor1August 8, 2022000api.fda.gov
Dentkist, Inc.Gunpo-si Gyeonggi, South KoreaManufacturer1March 8, 2016000api.fda.gov
DMP Dental Industry S.A.Markopoulo Attiki, GreeceContract manufacturer, Manufacturer1January 13, 2011000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer1September 16, 2009000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer1August 10, 1994000api.fda.gov
GC Europe N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer1January 22, 2003000api.fda.gov
GENOSS Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer1December 15, 2022000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer1November 7, 2022000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer1February 11, 2022000api.fda.gov
IPB IncOgden, UT, United StatesManufacturer1July 28, 2015000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesSpecification developer1February 25, 1997000api.fda.gov
Jiangxi Dentalbright Technology Co., LtdJiujiang City Jiangxi, ChinaExporter to the US, Manufacturer1July 28, 2021000api.fda.gov
Laxmi Dental LimitedPalghar Maharashtra, IndiaExporter to the US, Manufacturer1January 13, 2006000api.fda.gov
Major Prodotti Dentari S.P.A.MONCALIERI Torino, ItalyManufacturer1October 29, 1996000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoManufacturer1September 4, 2001000api.fda.gov
Nimi Chemical Industrial Co., Ltd.Kiryu Gunma, JapanManufacturer1October 18, 2002000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler1February 25, 1994000api.fda.gov
Prevest Denpro LimitedJammu Jammu and Kashmir, IndiaManufacturer1September 9, 2022000api.fda.gov
PSP Dental Co., Ltd.Belvedere, Kent, United KingdomComplaint file establishment, Manufacturer, Repackager or relabeler1April 21, 1986000api.fda.gov
Seilglobal Co., LtdBusan Gyeongnam, South KoreaManufacturer1February 23, 2015000api.fda.gov
Septodont Healthcare India Private Ltd.VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, IndiaExporter to the US, Manufacturer1November 20, 2003000api.fda.gov
Sherpa KoreaSaha-gu Busan, South KoreaManufacturer1February 11, 2011000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanySpecification developer1April 11, 2008000api.fda.gov
Spident Co., Ltd.INCHEON Gyeonggi, South KoreaManufacturer1September 30, 2016000api.fda.gov
Sunrise Dental Laboratory, Ltd.Kowloon, Hong Kong, ChinaExporter to the US, Manufacturer1April 3, 2003000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyComplaint file establishment, Specification developer1March 30, 2000000api.fda.gov
Sonrisa/Easy Denture/NSIWilmington, NC, United StatesSpecification developer1January 19, 2023000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer1April 14, 1981000api.fda.gov
Vannini Dental Industry SRLGRASSINA(FI) Firenze, ItalyManufacturer1November 14, 1996000api.fda.gov
Vigodent Industria E Comercio LtdaRio de Janeiro, BrazilManufacturer, Specification developer1October 31, 2025000api.fda.gov
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.Zhengzhou Henan, ChinaExporter to the US, Manufacturer1October 8, 2020000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Identa Dental Material GMBHCUXHAVEN Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.fda.gov
Kulzer SRLSacalaz-Judet Timis, RomaniaContract manufacturer0000api.fda.gov
Prisman GMBHLorsch Hesse, GermanyContract manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov

Updated September 16, 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.