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Data / Medical devices / System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations / United States

FDA-registered makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (product code NOF). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Product code
NOF
Country
United States

Makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer2December 5, 2014000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer2December 5, 2014000api.fda.gov
3D Imaging And Simulation Corp. AmericasHerndon, VA, United StatesManufacturer0000api.fda.gov
3Shape Inc.Morrisville, NC, United StatesContract manufacturer0000api.fda.gov
Atomica Technology, IncAtlanta, GA, United StatesManufacturer0000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Dentca, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesContract manufacturer0000api.fda.gov
Ori IncPleasant Grove, UT, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer0000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Reko Dental, LLCGardena, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesContract manufacturer0000api.fda.gov
X-Nav Technologies, LLC.Lansdale, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Zelia Dental Lab LLCN Brunswick, NJ, United StatesManufacturer0000api.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.