Data / Medical devices / Additively Manufactured, Preformed, Resin Denture Tooth / United States
FDA-registered makers of Additively Manufactured, Preformed, Resin Denture Tooth in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Additively Manufactured, Preformed, Resin Denture Tooth (product code PZY). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Additively Manufactured, Preformed, Resin Denture Tooth
- Product code
- PZY
- Country
- United States
Makers of Additively Manufactured, Preformed, Resin Denture Tooth in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dentca, Inc. | Irvine, CA, United States | Manufacturer | 1 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | York, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Inc. | Somerville, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Ohio, Inc. | Millbury, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Crown Dental Lab | Maspeth, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sprintray Inc. | Los Angeles, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sprintray Inc. | Huntington Beach, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.