Data / Medical devices / Teeth, Porcelain / United States
FDA-registered makers of Teeth, Porcelain in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Teeth, Porcelain (product code ELL). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Teeth, Porcelain
- Product code
- ELL
- Country
- United States
Makers of Teeth, Porcelain in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Keystone Dental Inc. | Irvine, CA, United States | Manufacturer | 1 | May 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 1 | March 16, 1993 | 0 | 0 | 0 | api.fda.gov |
| DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital Dental | Scottsdale, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare Procera, LLC | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silgan Unicep Packaging, LLC. | Sandpoint, ID, 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.