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Data / Medical devices / United States / Us Orthodontic Products

Us Orthodontic Products: FDA-registered device maker in Norwalk, CA, United States, 5 510(k) clearances

Us Orthodontic Products is registered with the FDA (registration 3008005217) in Norwalk, CA, United States. It lists 25 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 20, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3008005217
Address
11917 Front Street, Norwalk, CA, United States, 90650
Owner or operator
US Orthodontic Products (10036473)
Roles
Repackager or relabeler
First device listed
May 10, 2011
Registered through
2026
Brand names listed
Adhesive Bracket and Tooth Conditioner Resin, Adhesive Resin Bracket and Tooth Conditioner, BRACKET, AESTHETIC, ORTHODONTICS, BRACKET, METAL ORTHODONTIC, Dental Instrument, Dental Wax, Elastic Band, Impression Tray and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Band, Material, OrthodonticDYO1Repackager or relabeleraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Instrument, Contouring, Matrix, OperativeEKF1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Plate, Base, ShellacEEA1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Respirator, SurgicalMSH2Repackager or relabeleraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeleraccessdata.fda.gov
Shield, Protective, PersonnelKPY1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 20, 2009K083051FLOWTAIN & FLOWTAIN LVDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov
September 7, 2007K071688RELIANCE S.E.P.KLESubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov
January 3, 1995K945604ECLIPTOMERKLESubstantially EquivalentBisco, Inc.accessdata.fda.gov
December 28, 1992K924151BISCO D/C RESINOMEREBFSubstantially EquivalentBisco, Inc.accessdata.fda.gov
December 7, 1989K895522LIGHT BOND PASTE W/FLUORIDEDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov

Compare with other makers

Updated February 20, 2009. 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.