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
| Country | Makers |
|---|---|
| United States | 21 |
| Germany | 5 |
| Japan | 3 |
| Mexico | 2 |
| Israel | 1 |
| South Korea | 1 |
| Brazil | 1 |
| Sweden | 1 |
| Italy | 1 |
| Poland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Manufacturer for export, Repackager or relabeler, Specification developer | 22 | April 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Pomona, CA, United States | Complaint file establishment, Specification developer | 9 | January 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Specification developer | 9 | January 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| American Orthodontics | Sheboygan, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 8 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 7 | December 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Scientific Pharmaceuticals, Inc. | Pomona, CA, United States | Contract manufacturer, Manufacturer | 6 | July 21, 2000 | 0 | 0 | 0 | api.fda.gov |
| GC America Inc. | Alsip, IL, United States | Manufacturer, Repackager or relabeler | 5 | June 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 5 | June 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 5 | February 15, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer, Repackager or relabeler | 4 | September 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| B.J.M. Laboratories Ltd | OR-YEHUDA Central, Israel | Manufacturer | 3 | April 6, 2005 | 0 | 0 | 0 | api.fda.gov |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Manufacturer | 3 | August 10, 1994 | 0 | 0 | 0 | api.fda.gov |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 2 | November 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 2 | July 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 2 | July 14, 1995 | 0 | 0 | 0 | api.fda.gov |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | Manufacturer | 2 | October 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Irvine, CA, United States | Contract manufacturer, Manufacturer | 2 | December 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| TP Orthodontics, Inc. | La Porte, IN, United States | Manufacturer | 2 | October 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer | 2 | December 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Carlsbad, CA, United States | Repackager or relabeler, Specification developer | 2 | March 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer, Manufacturer | 1 | February 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Dentscare Ltda | Joinville Santa Catarina, Brazil | Manufacturer | 1 | August 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Gestenco International AB | GOTEBORG Vastra Gotaland, Sweden | Manufacturer | 1 | April 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Micerium S.P.A. | AVEGNO Genova, Italy | Manufacturer | 1 | January 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | Contract manufacturer, Manufacturer | 1 | October 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| S & C Polymer GMBH | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | August 20, 2003 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Manufacturer | 1 | December 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Solventum Poland Manufacturing SP. ZO.O | Wroclaw Dolnoslaskie, Poland | Manufacturer | 1 | February 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Specification developer | 1 | May 29, 1991 | 0 | 0 | 0 | api.fda.gov |
| Conamco SA de CV Medental Inc | C.P. 06880 Ciudad de Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Orange, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MANI MEDICAL GERMANY GmbH | Rosbach Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medmix Deutschland GmbH | Kiel Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.