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Data / Medical devices / Adhesive, Bracket And Tooth Conditioner, Resin

Adhesive, Bracket And Tooth Conditioner, Resin (DYH): 37 FDA-registered makers in 10 countries

37 establishments in 10 countries are registered with the FDA to make Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH, Class 2, 21 CFR 872.3750). 29 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 195 510(k) clearances under this code, the latest on October 13, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
DYH
Device class
2
Regulation
872.3750
Medical specialty
Dental

Makers by country

CountryMakers
United States21
Germany5
Japan3
Mexico2
Israel1
South Korea1
Brazil1
Sweden1
Italy1
Poland1

Makers of Adhesive, Bracket And Tooth Conditioner, 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
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesManufacturer for export, Repackager or relabeler, Specification developer22April 27, 2020000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer9January 3, 2025000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer9January 3, 2025000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler8June 3, 2026000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer7December 22, 2023000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer6July 21, 2000000api.fda.gov
GC America Inc.Alsip, IL, United StatesManufacturer, Repackager or relabeler5June 11, 2008000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer5June 11, 2008000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer5February 15, 2008000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler4September 7, 2011000api.fda.gov
B.J.M. Laboratories LtdOR-YEHUDA Central, IsraelManufacturer3April 6, 2005000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesManufacturer3August 10, 1994000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyExporter to the US, Manufacturer2November 21, 2003000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer2July 16, 2015000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer2July 14, 1995000api.fda.gov
Spident Co., Ltd.INCHEON Gyeonggi, South KoreaManufacturer2October 13, 2026000api.fda.gov
Solventum US LLCIrvine, CA, United StatesContract manufacturer, Manufacturer2December 22, 2023000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer2October 14, 2022000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer2December 1, 2023000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesRepackager or relabeler, Specification developer2March 18, 2015000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer, Manufacturer1February 7, 2012000api.fda.gov
Dentscare LtdaJoinville Santa Catarina, BrazilManufacturer1August 14, 2020000api.fda.gov
Gestenco International ABGOTEBORG Vastra Gotaland, SwedenManufacturer1April 5, 1999000api.fda.gov
Micerium S.P.A.AVEGNO Genova, ItalyManufacturer1January 17, 2008000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesContract manufacturer, Manufacturer1October 24, 2001000api.fda.gov
S & C Polymer GMBHELMSHORN Schleswig-Holstein, GermanyContract manufacturer, Manufacturer, Repackager or relabeler1August 20, 2003000api.fda.gov
Solventum Us LLCEagan, MN, United StatesManufacturer1December 22, 2023000api.fda.gov
Solventum Poland Manufacturing SP. ZO.OWroclaw Dolnoslaskie, PolandManufacturer1February 2, 2012000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesSpecification developer1May 29, 1991000api.fda.gov
Conamco SA de CV Medental IncC.P. 06880 Ciudad de Mexico, MexicoContract manufacturer0000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Kerr CorporationOrange, CA, United StatesContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesContract manufacturer0000api.fda.gov
MANI MEDICAL GERMANY GmbHRosbach Hesse, GermanyContract manufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
medmix Deutschland GmbHKiel Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov

Updated October 13, 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.