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Data / Medical devices / Crown, Preformed / United States

FDA-registered makers of Crown, Preformed in the United States: 29 establishments

29 establishments in the United States are registered with the FDA to make Crown, Preformed (product code ELZ). 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
Crown, Preformed
Product code
ELZ
Country
United States

Makers of Crown, Preformed in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Sprig Oral Health Technologies, Inc.Rocklin, CA, United StatesManufacturer1June 29, 2009000api.fda.gov
Artistic Dental Lab, Inc.Carrollton, TX, United StatesRemanufacturer0000api.fda.gov
Asap LLCSanta Fe Spgs, CA, United StatesManufacturer0000api.fda.gov
Aurum Ceramic Dental Laboratories LLCSpokane, WA, United StatesManufacturer0000api.fda.gov
Biohorizons Implant Systems Inc.Birmingham, AL, United StatesManufacturer0000api.fda.gov
Basic Dental Implant Systems, Inc.Rio Rancho, NM, United StatesManufacturer0000api.fda.gov
Cerlucent, LLCNorwalk, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Comdel Innovation, LLCWahpeton, ND, United StatesContract manufacturer0000api.fda.gov
Creodent Hudson ValleyFishkill, NY, United StatesManufacturer0000api.fda.gov
D&S Dental LaboratoryWaunakee, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Denovo Dental IncBaldwin Park, CA, United StatesManufacturer0000api.fda.gov
DENTSPLY IH Inc.Waltham, MA, United StatesManufacturer0000api.fda.gov
DSC Dental, LLCSaint George, UT, United StatesManufacturer0000api.fda.gov
Kinder KrownsEden Prairie, MN, United StatesManufacturer0000api.fda.gov
Nusmile, LtdHouston, TX, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Park-Istre, LLC.Dallas, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Peter Cheng Orthodontic Laboratories, Inc.Exton, PA, United StatesManufacturer0000api.fda.gov
Prime Dental Manufacturing, Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCShakopee, MN, United StatesContract manufacturer0000api.fda.gov
SKY DENT Corp for dental tradingNew York, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Specialty Appliances, LLCCumming, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Uscn Sourcing, LLCDallas, TX, United StatesSpecification developer0000api.fda.gov
Viarden Lab LLCMission, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
White Bite, Inc.Parrish, FL, United StatesSpecification developer0000api.fda.gov
Zelia Dental Lab LLCN Brunswick, NJ, United StatesManufacturer0000api.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.