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Data / Medical devices / Coating, Filling Material, Resin

Coating, Filling Material, Resin (EBD): 30 FDA-registered makers in 7 countries

30 establishments in 7 countries are registered with the FDA to make Coating, Filling Material, Resin (product code EBD, Class 2, 21 CFR 872.3310). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 52 510(k) clearances under this code, the latest on April 6, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EBD
Device class
2
Regulation
872.3310
Medical specialty
Dental

Makers by country

CountryMakers
United States11
Germany9
Japan6
South Korea1
China1
Liechtenstein1
India1

Makers of Coating, Filling Material, 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
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3March 6, 2014000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer3March 25, 1985000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer2October 12, 2001000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer2February 8, 2008000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Repackager or relabeler2November 22, 2021000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer1April 28, 2003000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer1December 12, 2024000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer1February 10, 1998000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer1April 5, 2018000api.fda.gov
GC Asahi CorporationAichi, JapanManufacturer1March 6, 2014000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer1October 20, 2005000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer1October 20, 2005000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer1March 6, 2014000api.fda.gov
Id Korea Co., Ltd.Dong-gu Gwangju, South KoreaManufacturer1June 4, 2025000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer1March 27, 2023000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer1April 9, 2004000api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer1August 16, 2017000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer1August 19, 1985000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer1October 24, 2008000api.fda.gov
Yamahachi Dental MFG. Co.Gamagori City Aichi, JapanComplaint file establishment, Manufacturer1April 6, 2026000api.fda.gov
Yamahachi Dental Material (Changshu) Co., Ltd.Changshu city Jiangsu, ChinaManufacturer1April 6, 2026000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer0000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer0000api.fda.gov
George Taub Products & Fusion Co., Inc.Jersey City, NJ, United StatesManufacturer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer0000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyExporter to the US, Specification developer0000api.fda.gov
Kulzer GMBHWEHRHEIM Hesse, GermanyContract manufacturer0000api.fda.gov
M/S Leixir Resources Pvt. LtdGURUGRAM Haryana, IndiaContract manufacturer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer0000api.fda.gov

Updated April 6, 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.