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Data / Medical devices / Material, Tooth Shade, Resin

Material, Tooth Shade, Resin (EBF): 132 FDA-registered makers in 22 countries

132 establishments in 22 countries are registered with the FDA to make Material, Tooth Shade, Resin (product code EBF, Class 2, 21 CFR 872.3690). 113 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 937 510(k) clearances under this code, the latest on September 21, 2026, and lists 16 recall events (0 Class I). FDA data exported November 2, 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
EBF
Device class
2
Regulation
872.3690
Medical specialty
Dental

Makers by country

CountryMakers
United States47
Germany22
South Korea12
Japan8
China8
Israel6
Switzerland5
Italy5
Brazil3
Mexico3
Turkey2
Liechtenstein1
Australia1
Greece1
United Kingdom1
Netherlands1
Spain1
India1
Czechia1
Austria1
France1
Colombia1

Makers of Material, Tooth Shade, Resin

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
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer36April 27, 2026010api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Manufacturer, Specification developer28August 31, 2022070api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer20January 9, 2019000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer17June 18, 2026000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer, Repackager or relabeler, Specification developer17July 1, 2026000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer16April 1, 2016000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer15December 17, 2024000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler15November 22, 2019000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer13September 27, 2016000api.fda.gov
Kuraray Noritake Dental Niigata PlantTAINAI Niigata, JapanManufacturer13November 18, 2019000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer12August 29, 2025000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Specification developer12March 11, 2026000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer12June 13, 2022000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer12June 13, 2022000api.fda.gov
Solventum US LLCIrvine, CA, United StatesContract manufacturer, Manufacturer12June 13, 2022000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler12July 1, 2026020api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler11October 15, 2024000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesManufacturer, Repackager or relabeler10July 2, 1996000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer10December 18, 2024000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer10August 23, 1991000api.fda.gov
Coltene/Whaledent AGALTSTAETTEN Sankt Gallen, SwitzerlandManufacturer9June 21, 2019000api.fda.gov
Kerr CorporationPomona, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer9August 31, 2022000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyContract manufacturer, Manufacturer, Specification developer9August 31, 2022000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer9August 28, 2015000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer, Repackager or relabeler8August 28, 2015000api.fda.gov
Sdi Ltd.BAYSWATER Victoria, AustraliaManufacturer8October 28, 2022000api.fda.gov
TOKUYAMA DENTAL CORPORATION Kashima FactoryKamisu-shi Ibaraki, JapanManufacturer8February 3, 2021000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer, Manufacturer7March 7, 2007000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer, Repackager or relabeler7October 1, 2009000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer, Repackager or relabeler7July 3, 2019000api.fda.gov
Dentscare LtdaJoinville Santa Catarina, BrazilManufacturer6October 18, 2024000api.fda.gov
Spident Co., Ltd.INCHEON Gyeonggi, South KoreaManufacturer6May 30, 2025000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer6May 11, 2026000api.fda.gov
indigodental GmbHPinneberg Schleswig-Holstein, GermanyExporter to the US, Manufacturer6November 17, 2010000api.fda.gov
Diadent Group InternationalCHONGJU CITY Chungbuk, South KoreaManufacturer5June 2, 2026000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer5January 31, 2018000api.fda.gov
Kettenbach GMBH & Co KGESCHENBURG Hesse, GermanyManufacturer, Repackager or relabeler5March 14, 2025000api.fda.gov
Mediclus Co., LtdCheongju-si Chungbuk, South KoreaManufacturer5December 5, 2025000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer5November 7, 2002000api.fda.gov
Aidite (qinhuangdao) Technology Co., LtdQinhuangdao City Hebei, ChinaManufacturer4April 6, 2026000api.fda.gov
B.J.M. Laboratories LtdOR-YEHUDA Central, IsraelManufacturer4November 7, 2025000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer4June 21, 2019000api.fda.gov
DENTSPLY DETREY GmbHKONSTANZ Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer4November 20, 2018000api.fda.gov
Meta Biomed Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer4October 8, 2024000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer, Repackager or relabeler4December 14, 2018000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Specification developer4November 7, 2025000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer4July 20, 2021000api.fda.gov
Rizhao Huge Biomaterials Company, Ltd.Rizhao Shandong, ChinaManufacturer4December 20, 2024000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler4September 23, 2022000api.fda.gov
Denali R & D CorporationHanover, MA, United StatesComplaint file establishment, Specification developer3February 26, 2016000api.fda.gov
DMP Dental Industry S.A.Markopoulo Attiki, GreeceContract manufacturer, Manufacturer3September 28, 2012000api.fda.gov
Essential Dental Systems, Inc.S Hackensack, NJ, United StatesRepackager or relabeler, Specification developer3May 30, 2025000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer3November 18, 2004000api.fda.gov
Hangzhou Shining3d Dental Technology Co., LtdHangzhou Zhejiang, ChinaManufacturer3April 27, 2026000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer3May 25, 2022000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer3April 15, 2026000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesSpecification developer3April 15, 2026000api.fda.gov
Advanced Healthcare Ltd.TONBRIDGE Kent, United KingdomManufacturer, Repackager or relabeler2August 15, 2007000api.fda.gov
Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KGBremen, GermanyManufacturer2November 9, 2023000api.fda.gov
Bicon, LLCBoston, MA, United StatesManufacturer2June 2, 2015000api.fda.gov
Bioloren SRLSARONNO Varese, ItalyManufacturer2February 24, 2018000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer2July 21, 2016000api.fda.gov
Cavex Holland B.V.HAARLEM Noord-Holland, NetherlandsManufacturer2December 4, 1998000api.fda.gov
Conamco SA de CV Medental IncC.P. 06880 Ciudad de Mexico, MexicoContract manufacturer, Manufacturer, Repackager or relabeler2April 2, 1999000api.fda.gov
Dsi Dental Solutions LtdAshdod Southern, IsraelRepackager or relabeler, Specification developer2May 23, 2025000api.fda.gov
GENOSS Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer2November 30, 2020000api.fda.gov
Graphenano Dental, SLPaterna Valencia(Province), SpainComplaint file establishment, Exporter to the US, Manufacturer2September 29, 2025000api.fda.gov
Graphy Inc.Seoul, South KoreaExporter to the US, Manufacturer2November 1, 2023000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer2August 9, 2022000api.fda.gov
Kavo Dental GMBHWARTHAUSEN Baden-Wurttemberg, GermanyManufacturer, Specification developer2October 14, 2009000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesManufacturer2November 17, 2015000api.fda.gov
Prevest Denpro LimitedJammu Jammu and Kashmir, IndiaManufacturer2November 27, 2024000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer2November 16, 2016000api.fda.gov
Saremco Dental AG9445 Rebstein Sankt Gallen, SwitzerlandComplaint file establishment, Manufacturer2June 27, 2024000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer2January 3, 2000000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer2August 17, 2000000api.fda.gov
Temrex Corp.Freeport, NY, United StatesManufacturer2October 5, 1990000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer, Repackager or relabeler2July 26, 2021000api.fda.gov
ADM, a.s.Brno Mesto Brno, CzechiaManufacturer1August 10, 1995000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer1May 31, 2013000api.fda.gov
ARUM DENTISTRY Co., Ltd.Yuseong-gu Daejeon, South KoreaManufacturer1September 11, 2024000api.fda.gov
Candulor, AGGlattpark Zurich, SwitzerlandForeign private label distributor, Specification developer1January 24, 2013000api.fda.gov
Cendres+metaux SABiel/Bienne Bern, SwitzerlandSpecification developer1November 13, 2017000api.fda.gov
Creamed GMBH & Co. Produktions- Und Handels KGMarburg Hesse, GermanyManufacturer1September 9, 2022000api.fda.gov
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital DentalScottsdale, AZ, United StatesSpecification developer1February 24, 2018000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor1August 16, 2022000api.fda.gov
Dentsply LLCYork, PA, United StatesManufacturer for export, Specification developer1June 10, 1994000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer1September 23, 2022000api.fda.gov
Edelweiss Dentistry Products GMBHWolfurt Vorarlberg, AustriaContract manufacturer, Manufacturer1October 18, 2024000api.fda.gov
GC Asahi CorporationAichi, JapanManufacturer1March 8, 2018000api.fda.gov
George Taub Products & Fusion Co., Inc.Jersey City, NJ, United StatesManufacturer1February 26, 2016000api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.Guilin Guangxi, ChinaManufacturer1August 31, 2026000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer1September 23, 2022000api.fda.gov
Itena Clinical VillepinteVillepinte Seine-Saint-Denis, FranceForeign private label distributor, Specification developer1March 5, 2013000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer1September 8, 2006000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer, Manufacturer1August 28, 2000000api.fda.gov
Liaoning Upcera Co.,LtdBenxi Liaoning, ChinaManufacturer1January 12, 2017000api.fda.gov
Merz Dental GMBHLUETJENBURG Schleswig-Holstein, GermanyManufacturer1December 18, 2017000api.fda.gov
Micerium S.P.A.AVEGNO Genova, ItalyManufacturer1November 17, 2006000api.fda.gov
MK-dent GmbHBargteheide Schleswig-Holstein, GermanyContract manufacturer, Manufacturer1October 24, 2002000api.fda.gov
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.SAO CARLOS Sao Paulo, BrazilManufacturer1April 23, 2026000api.fda.gov
New SteticGUARNE Antioquia, ColombiaManufacturer1March 3, 2026000api.fda.gov
Nobio Ltd.Kadima Central, IsraelComplaint file establishment, Manufacturer1August 14, 2020000api.fda.gov
Ribbond, Inc.Racine, WI, United StatesManufacturer, Specification developer1May 3, 2002000api.fda.gov
Shenzhen Piocreat 3D Technology Co., LtdShenzhen Guangdong, ChinaManufacturer1October 15, 2024000api.fda.gov
Shiga Shofu Inc.Koka Shiga, JapanContract manufacturer, Manufacturer1February 5, 2021000api.fda.gov
Silmet Ltd.OR YEHUDA Tel Aviv, IsraelManufacturer1February 2, 2011000api.fda.gov
Sincera Technology (changchun) Co., LtdChangchun City Jilin, ChinaManufacturer1March 15, 2024000api.fda.gov
Sino-Dentex Co.,ltdChangchun Jilin, ChinaManufacturer1November 14, 2018000api.fda.gov
Smart Denture Conversions, LLCApex, NC, United StatesRepackager or relabeler, Specification developer1February 24, 2018000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1April 30, 1997000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer1June 18, 2018000api.fda.gov
anax dent GmbHStuttgart Baden-Wurttemberg, GermanyManufacturer1January 26, 2012000api.fda.gov
3bfab Teknoloji Anonim SirketiIstanbul, TurkeyManufacturer0000api.fda.gov
Clemde S.A. De C.V.MEXICO, DF Ciudad de Mexico, MexicoManufacturer0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Dentkist, Inc.Gunpo-si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Harvest Dental Products LLCBrea, CA, United StatesManufacturer0000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer0000api.fda.gov
Id Korea Co., Ltd.Dong-gu Gwangju, South KoreaManufacturer0000api.fda.gov
Identa Dental Material GMBHCUXHAVEN Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Idoc Dental LabOrange, CA, United StatesContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing GmbHNATURNO (BZ) Bolzano, ItalyContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.fda.gov
MANI MEDICAL GERMANY GmbHRosbach Hesse, GermanyContract manufacturer0000api.fda.gov
Oxford Performance Materials, Inc.South Windsor, CT, United StatesContract manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
SMD Dental LaboratoryHeungdeok-gu Cheongju-si Chungbuk, South KoreaContract manufacturer0000api.fda.gov
Stratasys LtdKiryat Gat Southern, IsraelManufacturer0000api.fda.gov
STRATASYS LTD - HeadquarterRehovot Central, IsraelComplaint file establishment, Specification developer0000api.fda.gov
medmix Deutschland GmbHKiel Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov

Updated September 21, 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.