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Data / Medical devices / United States / Ortho Solutions LC

Ortho Solutions LC: FDA-registered device maker in Lake Saint Louis, MO, United States, 15 510(k) clearances

Ortho Solutions LC is registered with the FDA (registration 1937100) in Lake Saint Louis, MO, United States. It lists 50 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 5, 2023. Registered through 2027. 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.

Get makers like this oneWatch Ortho Solutions LC
FDA registration number
1937100
Address
8050 Hawk Ridge Trail, Lake Saint Louis, MO, United States, 63367
Owner or operator
Ortho Solutions LC (1937100)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
September 2, 2011
Registered through
2027
Brand names listed
Adjustable Herbst, DISK GUARD, Dorsal Appliance, Dyna Ice, Chill Spray, Ortho-Ice, DynaFlex Bonding Brushes, DynaFlex FACE BOW, EMA, EZ Align and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Aligner, SequentialNXC2Manufactureraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Band, Material, OrthodonticDYO1Repackager or relabeleraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Repackager or relabeleraccessdata.fda.gov
Device, Anti-SnoringLRK2Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Jaw RepositioningLQZ2Manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Repackager or relabeleraccessdata.fda.gov
Driver, Band, OrthodonticECT1Repackager or relabeleraccessdata.fda.gov
FacebowKCR1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Guard, DiskEEJ1Repackager 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 HandDZN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Manufactureraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Repackager or relabeleraccessdata.fda.gov
Respirator, SurgicalMSH2Repackager or relabeleraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeleraccessdata.fda.gov
Setter, Band, OrthodonticECR1Repackager or relabeleraccessdata.fda.gov
Sleep Appliances With Patient MonitoringPLC2Manufactureraccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Strip, Polishing AgentEHM1Repackager or relabeleraccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Repackager or relabeleraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Repackager or relabeleraccessdata.fda.gov
Tester, PulpEAT2Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager 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
Zinc Oxide EugenolEMB1Repackager 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 5, 2023K230225DynaFlex Clear Brackets & ButtonsNJMSubstantially EquivalentDyna Flexaccessdata.fda.gov
May 31, 2022K214096Respire ClearLRKSubstantially EquivalentRespire Medical, LLCaccessdata.fda.gov
February 5, 2020K192127Respire Pink AT (Hard, Hard/Soft, EF)LRKSubstantially EquivalentRespire Medical Holdingsaccessdata.fda.gov
June 27, 2019K190583DynaFlexNXCSubstantially EquivalentDyna Flexaccessdata.fda.gov
May 26, 2017K170692Respire Pink Series with DentiTracLRKSubstantially EquivalentRespire Medical Holdingaccessdata.fda.gov
December 7, 2015K152292Respire Blue Series-EFLRKSubstantially EquivalentRespire Medical Holdingaccessdata.fda.gov
August 27, 2015K150572Respire Pink Series-Herbst-EFLRKSubstantially EquivalentRespire Medical Holdingaccessdata.fda.gov
February 9, 2015K141421PMMA BLOCKEBGSubstantially EquivalentRizhao Huge Dental Industry Co., Ltd.accessdata.fda.gov
September 9, 2013K131138RESPIRE PINK SERIES - HERBSTLRKSubstantially EquivalentRespire Medicalaccessdata.fda.gov
June 4, 2012K120471MACH BRACKETS BRIGHT BRACKETSNJMSubstantially EquivalentWorld Bio Tech Co., Ltd.accessdata.fda.gov
August 23, 2011K111207RESPIRE BLUE SERIESLRKSubstantially EquivalentRespire Medicalaccessdata.fda.gov
February 23, 2011K103076DYNAFLEXLRKSubstantially EquivalentDyna Flexaccessdata.fda.gov
May 27, 2009K090567ORTHODONTIC CERAMIC BRACKETNJMSubstantially EquivalentStar Dentech Korea., Corpaccessdata.fda.gov
December 3, 2008K082408LEDEX, MODEL: WL-070EBZSubstantially EquivalentDentmate Technology Co. , Ltd.accessdata.fda.gov
December 13, 1995K955292AELITEFLOEBFSubstantially EquivalentBisco, Inc.accessdata.fda.gov

Compare with other makers

Updated June 5, 2023. 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.