Dental Device Guide
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Manufacturer registered with FDA

Ortho Solutions LC

Lake Saint Louis, MO, United States. Lists 45 dental device types with FDA across 1 registered establishment.

FDA owner/operator1937100Contract manufacturerManufacturerRepacker / relabeler
Device types listed
45
Brands and models
25
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United States

Devices listed with FDA

What Ortho Solutions LC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Anti-Snoring DeviceLRK · Class 2Anti-snoring & jaw-repositioning devicesMaker
Adjustable HerbstDorsal ApplianceEMALISA II®LISA®Respire Blue EF+; Respire Pink EF MicroRespire Blue SeriesRespire MedicalRespire Pink AT SeriesRespire Pink DeniTrac® Hard; Respire Pink DeniTrac® Hard/Soft
5 more
Respire Pink SeriesRespire Pink Series-EFTAP-1TAP-3 & EliteWhite Night
2012
Orthodontic Ceramic BracketNJM · Class 2Orthodontic bracketsMaker
Norris Clear System
2014
Jaw Repositioning DeviceLQZ · Class 2Anti-snoring & jaw-repositioning devicesMaker
Respire MedicalWhite Night
2023
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearLister—2011
Orthodontic Material BandDYO · Class 1Orthodontic wires & bandsLister—2011
Orthodontic Space Preformed MaintainerDYT · Class 1Retainers, expanders & headgearMaker—2011
Orthodontic WireDZC · Class 1Orthodontic wires & bandsLister—2011
Orthodontic TubeDZD · Class 1Orthodontic wires & bandsLister—2011
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2017
Dental Diamond InstrumentDZP · Class 1Dental burs & diamondsLister—2016
Pulp TesterEAT · Class 2—Lister
Dyna Ice, Chill Spray, Ortho-Ice
2017
Mouth MirrorEAX · Class 1Dental hand instrumentsLister
Photographic Mirror
2013
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister—2016
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsLister—2018
Resin Impression Tray MaterialEBH · Class 1Impression traysLister—2018
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsLister—2017
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsMaker—2011
Orthodontic Preformed BandECM · Class 1Orthodontic wires & bandsLister—2011
Orthodontic Wire ClampECN · Class 1—Lister—2011
Orthodontic SpringECO · Class 1Orthodontic wires & bandsLister—2011
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsLister—2011
Orthodontic Bracket AlignerECQ · Class 1Dental hand instrumentsLister—2011
Orthodontic Band SetterECR · Class 1Dental hand instrumentsLister—2011
Orthodontic Band PusherECS · Class 1Dental hand instrumentsLister—2011
Orthodontic Band DriverECT · Class 1Dental hand instrumentsLister—2011
Disk GuardEEJ · Class 1—Lister
DISK GUARD
2018
Manual ToothbrushEFW · Class 1ToothbrushesLister—2016
Intraoral Dental WaxEGD · Class 1—Lister—2011
Abrasive DiskEHJ · Class 1Polishing & prophylaxisLister—2018
Polishing Agent StripEHM · Class 1Polishing & prophylaxisLister—2016
Preformed Impression TrayEHY · Class 1Impression traysLister—2019
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker—2014
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsLister—2019
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsLister—2011
Dental BurEJL · Class 1Dental burs & diamondsLister—2011
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisLister—2018
Zinc Oxide EugenolEMB · Class 1Dental cementsLister—2017
Dental FlossJES · Class 1Floss & interdental cleanersLister—2016
Orthodontic PlierJEX · Class 1Dental hand instrumentsLister—2011
FacebowKCR · Class 1Articulators & facebowsLister
DynaFlex FACE BOW
2026
Preformed Tooth PositionerKMY · Class 1Retainers, expanders & headgearMaker—2017
Resin ApplicatorKXR · Class 1—Lister
DynaFlex Bonding Brushes
2014
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersLister—2013
Sequential AlignerNXC · Class 2Clear alignersMaker
EZ Align
2019
Sleep Appliances with Patient MonitoringPLC · Class 2—Maker
Respire Pink DeniTrac® Hard; Respire Pink DeniTrac® Hard/Soft
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Ortho Solutions LC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Dyna Flex (3), Respire Medical, LLC (3), Respire Medical Holding (3), Respire Medical Holdings (1), Rizhao Huge Dental Industry Co., Ltd. (1), World Bio Tech Co Ltd (1), Star Dentech Korea., Corp (1), Dentmate Technology Co. , Ltd. (1).

Decided510(k)DeviceApplicantDevice type
5 Jun 2023K230225DynaFlex Clear Brackets & ButtonsDyna FlexNJM Orthodontic Ceramic Bracket
31 May 2022K214096Respire ClearRespire Medical, LLCLRK Anti-Snoring Device
5 Feb 2020K192127Respire Pink AT (Hard, Hard/Soft, EF)Respire Medical HoldingsLRK Anti-Snoring Device
27 Jun 2019K190583DynaFlexDyna FlexNXC Sequential Aligner
26 May 2017K170692Respire Pink Series with DentiTracRespire Medical HoldingLRK Anti-Snoring Device
7 Dec 2015K152292Respire Blue Series-EFRespire Medical HoldingLRK Anti-Snoring Device
27 Aug 2015K150572Respire Pink Series-Herbst-EFRespire Medical HoldingLRK Anti-Snoring Device
9 Feb 2015K141421PMMA BLOCKRizhao Huge Dental Industry Co., Ltd.EBG Resin Temporary Crown and Bridge
9 Sep 2013K131138RESPIRE PINK SERIES - HERBSTRespire Medical, LLCLRK Anti-Snoring Device
4 Jun 2012K120471MACH BRACKETS BRIGHT BRACKETSWorld Bio Tech Co LtdNJM Orthodontic Ceramic Bracket
23 Aug 2011K111207RESPIRE BLUE SERIESRespire Medical, LLCLRK Anti-Snoring Device
23 Feb 2011K103076DYNAFLEXDyna FlexLRK Anti-Snoring Device
27 May 2009K090567ORTHODONTIC CERAMIC BRACKETStar Dentech Korea., CorpNJM Orthodontic Ceramic Bracket
3 Dec 2008K082408LEDEX, MODEL: WL-070Dentmate Technology Co. , Ltd.EBZ Ultraviolet Activator for Polymerization
13 Dec 1995K955292AELITEFLOBisco, Inc.EBF Resin Tooth Shade Material

Registered establishments

EstablishmentLocationWhat it does
Ortho Solutions LCFDA reg. 1937100Lake Saint Louis, MO, United StatesContract manufacturer, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1937100). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.