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Data / Medical devices / Resin, Denture, Relining, Repairing, Rebasing

Resin, Denture, Relining, Repairing, Rebasing (EBI): 132 FDA-registered makers in 27 countries

132 establishments in 27 countries are registered with the FDA to make Resin, Denture, Relining, Repairing, Rebasing (product code EBI, Class 2, 21 CFR 872.3760). 96 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 335 510(k) clearances under this code, the latest on August 27, 2026, and lists 9 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
EBI
Device class
2
Regulation
872.3760
Medical specialty
Dental

Makers by country

CountryMakers
United States54
Germany20
China12
Japan6
Italy5
Brazil4
United Kingdom4
South Korea3
Israel3
Australia2
Mexico2
Spain2
Netherlands1
Liechtenstein1
Finland1
Trinidad and Tobago1
Canada1
Turkey1
South Africa1
France1
Taiwan1
Colombia1
Slovenia1
Switzerland1
Romania1
India1
Philippines1

Makers of Resin, Denture, Relining, Repairing, Rebasing

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
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler18March 3, 2016000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer9May 20, 2025000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer, Repackager or relabeler8June 23, 2023000api.fda.gov
Lang Dental MFG. Co., Inc.Wheeling, IL, United StatesComplaint file establishment, Manufacturer7September 2, 2016010api.fda.gov
Vertex-Dental B.V.Soesterberg Utrecht, NetherlandsManufacturer7September 4, 2024000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer6December 17, 2024000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer, Specification developer6February 23, 2024000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Repackager or relabeler, Specification developer6May 5, 2021000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler6October 24, 2024010api.fda.gov
Stick Tech Ltd.TURKU Pirkanmaa, FinlandComplaint file establishment, Manufacturer6April 10, 2003000api.fda.gov
The Myerson Company LimitedLaventille San JuanLaventille, Trinidad and TobagoContract manufacturer, Manufacturer, Specification developer5April 13, 2023000api.fda.gov
Keystone IndustriesCherry Hill, NJ, United StatesManufacturer4October 24, 2024000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler4August 27, 2026000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer4April 29, 2025000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesSpecification developer4April 29, 2025000api.fda.gov
ST. George Technology, Inc.Wilmington, NC, United StatesSpecification developer4February 10, 2000000api.fda.gov
Yamahachi Dental Material (Changshu) Co., Ltd.Changshu city Jiangsu, ChinaManufacturer4March 5, 2024000api.fda.gov
Aidite (qinhuangdao) Technology Co., LtdQinhuangdao City Hebei, ChinaManufacturer3November 22, 2024000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer3October 30, 2025000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer3July 9, 1999000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesSpecification developer3November 4, 2011000api.fda.gov
Myerson LLCChicago, IL, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler3April 13, 2023000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer3January 26, 2006000api.fda.gov
Proto3000 Inc.Vaughan Ontario, CanadaManufacturer3November 1, 2019000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer3May 6, 2026000api.fda.gov
Thermoplastic Comfort Systems, Inc.Signal Hill, CA, United StatesComplaint file establishment, Manufacturer3February 3, 2015000api.fda.gov
TOKUYAMA DENTAL CORPORATION Kashima FactoryKamisu-shi Ibaraki, JapanManufacturer3October 4, 2019000api.fda.gov
Yamahachi Dental MFG. Co.Gamagori City Aichi, JapanComplaint file establishment, Specification developer3March 5, 2024000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer2April 6, 2023000api.fda.gov
Dentca, Inc.Irvine, CA, United StatesManufacturer2November 17, 2022000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer2March 23, 2021000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer2September 22, 1999000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanExporter to the US, Manufacturer2March 3, 2016000api.fda.gov
Guangzhou Heygears Imc.incGuangzhou Guangdong, ChinaSpecification developer2August 13, 2026000api.fda.gov
Graphy Inc.Seoul, South KoreaExporter to the US, Manufacturer2November 21, 2025000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesManufacturer2January 25, 2002000api.fda.gov
Major Prodotti Dentari S.P.A.MONCALIERI Torino, ItalyManufacturer2November 25, 2008000api.fda.gov
Merz Dental GMBHLUETJENBURG Schleswig-Holstein, GermanyManufacturer2September 15, 2014000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer2June 20, 2024000api.fda.gov
Ribbond, Inc.Racine, WI, United StatesManufacturer, Specification developer2January 25, 2002000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer, Repackager or relabeler2June 26, 2001000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer2September 22, 1999000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler2November 16, 2020000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer2June 16, 2014000api.fda.gov
3bfab Teknoloji Anonim SirketiIstanbul, TurkeyManufacturer1July 31, 2026000api.fda.gov
Ad Systems And ConsultingSilver Lakes, Pretoria Gauteng, South AfricaManufacturer1March 31, 2025000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilExporter to the US, Manufacturer1December 17, 2008000api.fda.gov
AsigaAlexandria New South Wales, AustraliaManufacturer1April 11, 2025000api.fda.gov
Bio Composants Medicaux (BCM)SAINT BLAISE DU BUIS Isere, FranceContract manufacturer, Manufacturer1November 23, 2010000api.fda.gov
Bioloren SRLSARONNO Varese, ItalyManufacturer1September 8, 2006000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer1December 21, 2005000api.fda.gov
Carbon, Inc.Sunnyvale, CA, United StatesComplaint file establishment, Specification developer1June 2, 2026000api.fda.gov
CFS Dental IncHialeah, FL, United StatesManufacturer, Repackager or relabeler1January 22, 2009000api.fda.gov
Clemde S.A. De C.V.MEXICO, DF Ciudad de Mexico, MexicoManufacturer1November 27, 2023000api.fda.gov
Comfort Acrylics, Inc.Camas, WA, United StatesManufacturer1May 15, 1990000api.fda.gov
Candulor Dental GmbHRielasingen-Worblingen Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer1October 17, 1991000api.fda.gov
Davis Schottlander & Davis, Ltd.LETCHWORTH, HERTS. Hertfordshire, United KingdomExporter to the US, Repackager or relabeler, Specification developer1December 22, 1999000api.fda.gov
Degudent GMBHHANAU Hesse, GermanyManufacturer1December 18, 2018000api.fda.gov
DENKEN-HIGHDENTAL Co., Ltd.Kyoto, JapanComplaint file establishment, Manufacturer1July 26, 2013000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer, Manufacturer1October 12, 2007000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer1November 19, 2020000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer1June 16, 2014000api.fda.gov
Dental Direkt GmbHSpenge North Rhine-Westphalia, GermanyManufacturer1June 23, 2023000api.fda.gov
Enlighten Materials Co., Ltd.Taipei City, TaiwanSpecification developer1August 18, 2020000api.fda.gov
Formlabs Inc.Somerville, MA, United StatesComplaint file establishment, Specification developer1July 8, 2026000api.fda.gov
Formlabs Ohio, Inc.Millbury, OH, United StatesComplaint file establishment, Manufacturer1July 8, 2026000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer1March 3, 2016000api.fda.gov
Hangzhou Shining3d Dental Technology Co., LtdHangzhou Zhejiang, ChinaManufacturer1March 31, 2025000api.fda.gov
Harvest Dental Products LLCBrea, CA, United StatesManufacturer1August 16, 2023000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer1June 20, 2024000api.fda.gov
Imagine Milling Technologies, LLCChantilly, VA, United StatesRemanufacturer, Repackager or relabeler1June 30, 2017000api.fda.gov
J. Morita Usa, Inc.Irvine, CA, United StatesRepackager or relabeler, Specification developer1June 6, 2006000api.fda.gov
JBC And CompanyFredericksburg, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler1February 24, 1998000api.fda.gov
Kettenbach GMBH & Co KGESCHENBURG Hesse, GermanyManufacturer1November 13, 1998000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer1November 25, 2025000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoManufacturer1September 22, 1999000api.fda.gov
Micerium S.P.A.AVEGNO Genova, ItalyManufacturer1January 12, 2007000api.fda.gov
New SteticGUARNE Antioquia, ColombiaManufacturer1March 28, 2011000api.fda.gov
Ningbo Sezen Technology Co., Ltd.Ningbo Zhejiang, ChinaManufacturer1November 25, 2025000api.fda.gov
Pan-Am Dental, Inc.Sandy, UT, United StatesManufacturer1April 16, 1990000api.fda.gov
Perflex LtdNetanya Central, IsraelManufacturer1May 26, 2015000api.fda.gov
POLIDENT d.o.o., Dental products industryVOLCJA DRAGA Rence-Vogrsko, SloveniaManufacturer1September 28, 2016000api.fda.gov
Polydentia S.A.MEZZOVICO-Vira Ticino, SwitzerlandManufacturer1July 22, 1996000api.fda.gov
Pro3dure Medical GMBHIserlohn North Rhine-Westphalia, GermanyManufacturer1May 5, 2021000api.fda.gov
PSP Dental Co., Ltd.Belvedere, Kent, United KingdomComplaint file establishment, Manufacturer, Repackager or relabeler1April 4, 1986000api.fda.gov
Reliance Dental MFG., LLCAlsip, IL, United StatesManufacturer1September 23, 1985000api.fda.gov
Riton 3D Technology Co., LtdGuangzhou Guangdong, ChinaManufacturer1December 23, 2024000api.fda.gov
Schuetz Dental GMBHROSBACH Hesse, GermanyManufacturer1October 26, 2005000api.fda.gov
Shen Fu Arts LabShen Zhen Guangdong, ChinaManufacturer1March 12, 1980000api.fda.gov
Stratasys LtdKiryat Gat Southern, IsraelManufacturer1July 7, 2022000api.fda.gov
STRATASYS LTD - HeadquarterRehovot Central, IsraelComplaint file establishment, Specification developer1July 7, 2022010api.fda.gov
Talon Acrylics, Inc.Winchester, OR, United StatesManufacturer, Repackager or relabeler, Reprocessor1August 2, 2007000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer1June 20, 2024000api.fda.gov
Wright Health GroupDundee Dundee City, United KingdomManufacturer1September 5, 2001000api.fda.gov
Zirkonzahn SRLGais Bolzano, ItalyManufacturer1September 5, 2023000api.fda.gov
anax dent GmbHStuttgart Baden-Wurttemberg, GermanyManufacturer1October 26, 2005000api.fda.gov
Bicon, LLCBoston, MA, United StatesManufacturer0000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer0000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesManufacturer0000api.fda.gov
Co-Oral-Ite Dental MFG. Co.Diamond Springs, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Davis Dental LabWyoming, MI, United StatesContract manufacturer0000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor0000api.fda.gov
Dentsply Industria E Comercio LtdaPIRASSUNUNGA Sao Paulo, BrazilContract manufacturer0000api.fda.gov
DMG Digital Enterprises SeHamburg, GermanyManufacturer0000api.fda.gov
Esstech, IncEssington, PA, United StatesContract manufacturer0000api.fda.gov
Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda.Pirassununga Sao Paulo, BrazilManufacturer0000api.fda.gov
Fricke Dental MFG. Co.Streamwood, IL, United StatesManufacturer0000api.fda.gov
Graphenano Dental, SLPaterna Valencia(Province), SpainManufacturer0010api.fda.gov
Huliang (shanghai) Bio-Tech Co., Ltd.Shanghai, ChinaManufacturer0000api.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
Jiangxi Heygears Innovative Material Co., LtdJiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.fda.gov
Kulzer SRLSacalaz-Judet Timis, RomaniaContract manufacturer0000api.fda.gov
Liaoning Upcera Co.,LtdBenxi Liaoning, ChinaManufacturer0000api.fda.gov
M/S Leixir Resources Pvt. LtdGURUGRAM Haryana, IndiaContract manufacturer0000api.fda.gov
Makevale, Ltd.Ware, Hertfordshire, United KingdomManufacturer0000api.fda.gov
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.SAO CARLOS Sao Paulo, BrazilManufacturer0000api.fda.gov
Myohealth Technologies, LLCPortland, OR, United StatesManufacturer0000api.fda.gov
Shenzhen Piocreat 3D Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Somnomed Inc.Plano, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Somnomed, Ltd.CROWS NEST New South Wales, AustraliaSpecification developer0000api.fda.gov
SomnoMed Phillipines Inc.Makati City National Capital Region, PhilippinesManufacturer0000api.fda.gov
Union Dental S.A.TIELMES Madrid(Province), SpainManufacturer0000api.fda.gov
Valplast Intl. Corp.E Northport, NY, United StatesManufacturer0000api.fda.gov
Vynacron Dental Resins, Inc.Jackson, NJ, United StatesManufacturer0000api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesManufacturer0000api.fda.gov
Yates-MotloidElmhurst, IL, United StatesManufacturer0000api.fda.gov

Updated August 27, 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.