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Data / Medical devices / United States / Xplora USA LLC

Xplora USA LLC: FDA-registered device maker in Carrollton, TX, United States, 14 510(k) clearances

Xplora USA LLC is registered with the FDA (registration 3008882689) in Carrollton, TX, United States. It lists 24 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 2, 2021. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Xplora USA LLC
FDA registration number
3008882689
Address
1501 Randolph St Ste K16, Carrollton, TX, United States, 75006
Owner or operator
Xplora USA LLC (10089697)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
December 29, 2023
Registered through
2026
Brand names listed
Lammina, Six Month Smiles

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Aligner, SequentialNXC2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Repackager or relabeleraccessdata.fda.gov
Heat Source For Bleaching TeethEEG1Repackager or relabeleraccessdata.fda.gov
Indirect Bonding TrayQJJ1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Repackager or relabeleraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Teeth, Artificial, Backing And FacingELK1Complaint file establishment, Manufacturer, Repackager 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
June 2, 2021K2106526MS Invisible AlignerNXCSubstantially EquivalentSms Opco, LLCaccessdata.fda.gov
November 12, 2014K140807COMPOSITE ORTHODONTIC BRACKETSDYWSubstantially EquivalentOrtho Specialtiesaccessdata.fda.gov
April 11, 2014K131734ALL-BOND UNIVERSAL SC (NOT FINALIZED)KLESubstantially EquivalentBisco, Inc.accessdata.fda.gov
November 27, 2012K121093D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000EBZSubstantially EquivalentDxm Co., Ltd.accessdata.fda.gov
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
July 31, 2007K071590THERMA-CUREDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov
February 2, 2007K063593CLEARFIL MAJESTY FLOWEBFSubstantially EquivalentKuraray America, Inc.accessdata.fda.gov
February 1, 2006K053103INTERFACEKLESubstantially EquivalentApex Dental Materials, Inc.accessdata.fda.gov
November 21, 1997K973776REFLECTIONSDYWSubstantially EquivalentCdb Corp.accessdata.fda.gov
December 8, 1989K895523PHASE II ORTHODONTIC ADHESIVEDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov
December 7, 1989K895522LIGHT BOND PASTE W/FLUORIDEDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov
April 18, 1988K880790PORCELAIN PRIMERDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov
February 29, 1988K875142PHASE IIDYHSubstantially EquivalentReliance Orthodontic Products, Inc.accessdata.fda.gov

Compare with other makers

Updated June 2, 2021. 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.