Data / Medical devices / Powder, Porcelain / United States
FDA-registered makers of Powder, Porcelain in the United States: 30 establishments
30 establishments in the United States are registered with the FDA to make Powder, Porcelain (product code EIH). 26 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Powder, Porcelain
- Product code
- EIH
- Country
- United States
Makers of Powder, Porcelain in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 18 | July 30, 2026 | 0 | 1 | 0 | api.fda.gov |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | 7 | February 3, 2017 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Specification developer | 6 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Jensen Industries, Inc. | North Haven, CT, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 6 | March 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Talladium, Inc. | Santa Clarita, CA, United States | Manufacturer | 5 | September 15, 2016 | 0 | 1 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 5 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 5 | October 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital Dental | Scottsdale, AZ, United States | Specification developer | 4 | May 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Imagine Milling Technologies, LLC | Chantilly, VA, United States | Contract manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 4 | February 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sagemax Bioceramics, Inc. | Federal Way, WA, United States | Specification developer | 4 | December 16, 2015 | 0 | 1 | 0 | api.fda.gov |
| United Dental Resources Corporation | University Park, IL, United States | Manufacturer | 3 | February 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Amsusa LLC | Atlanta, GA, United States | Manufacturer, Specification developer | 1 | May 4, 2017 | 0 | 0 | 0 | api.fda.gov |
| B And D Dental Corporation | West Valley City, UT, United States | Manufacturer | 1 | August 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer, Manufacturer | 1 | March 31, 1993 | 0 | 0 | 0 | api.fda.gov |
| BMF Precision, Inc. | Maynard, MA, United States | Complaint file establishment, Specification developer | 1 | April 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ceragroup Industries | Fort Lauderdale, FL, United States | Contract manufacturer, Manufacturer | 1 | August 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer | 1 | August 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY IH Inc. | Waltham, MA, United States | Manufacturer | 1 | January 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Hiossen, Inc. | Morrisville, PA, United States | Manufacturer | 1 | October 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Keystone Industries - Gibbstown | Gibbstown, NJ, United States | Contract manufacturer, Manufacturer | 1 | March 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 1 | March 31, 1993 | 0 | 0 | 0 | api.fda.gov |
| Seattle Bioceramics, Inc. | Kent, WA, United States | Manufacturer | 1 | May 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 1 | November 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | November 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Irvine, CA, United States | Manufacturer | 1 | November 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 1 | May 10, 1995 | 0 | 0 | 0 | api.fda.gov |
| DS Rep B.V. | Las Piedras, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Idoc Dental Lab | Orange, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing, Inc | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.