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Data / Medical devices / Bracket, Ceramic, Orthodontic / United States

FDA-registered makers of Bracket, Ceramic, Orthodontic in the United States: 14 establishments

14 establishments in the United States are registered with the FDA to make Bracket, Ceramic, Orthodontic (product code NJM). 12 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
Bracket, Ceramic, Orthodontic
Product code
NJM
Country
United States

Makers of Bracket, Ceramic, Orthodontic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
LightForce OrthodonticsWilmington, MA, United StatesManufacturer5September 14, 2023000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer3July 7, 2023000api.fda.gov
CDB CorporationLeland, NC, United StatesContract manufacturer, Manufacturer3September 27, 2016000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer3March 8, 2018000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3January 31, 2018000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer3January 31, 2018000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer, Repackager or relabeler3June 5, 2023000api.fda.gov
G & H Wire CompanyFranklin, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler2May 4, 2023000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2December 21, 2012000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2March 16, 2018000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer2May 13, 2011000api.fda.gov
World Class Technology CorporationMcminnville, OR, United StatesManufacturer1November 12, 2019000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer0000api.fda.gov
Solventum US LLCIrvine, CA, United StatesContract manufacturer0000api.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.