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Data / Medical devices / United States / Rmo

Rmo: FDA-registered device maker in Franklin, IN, United States, 10 510(k) clearances

Rmo is registered with the FDA (registration 1718476) in Franklin, IN, United States. It lists 35 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 15, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1718476
Address
2165 Earlywood Drive, Franklin, IN, United States, 46131
Owner or operator
RMO (10078580)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 28, 2020
Registered through
2026
Brand names listed
Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock, Alice Composite, Alice Composite Roth, Alice Composite Edgewise system, Bendaloy Titanium, Niti Coil Spring; Elgiloy; FLI Copper and FLI Aesthetic; Orthonol, Thermaloy Plus, Bond Placement Tweezer / band and bracket removers; Cutters; Wire bending pliers, Bridging wire; Silver Solder, Cheek Retractor, Dual Top, Dual Top and Orthonia endosseous dental implant tools and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager 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
Alloy, Other Noble MetalEJS2Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Band, Material, OrthodonticDYO1Manufactureraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Manufactureraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Repackager or relabeleraccessdata.fda.gov
Clasp, PreformedEHP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Driver, Band, OrthodonticECT1Manufactureraccessdata.fda.gov
Headgear, Extraoral, OrthodonticDZB2Repackager or relabeleraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Repackager or relabeleraccessdata.fda.gov
Protector, DentalBRW1Repackager or relabeleraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Repackager or relabeleraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Spring, OrthodonticECO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Manufacturer, Repackager 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
November 15, 2019K182672ROSA BracketNJMSubstantially EquivalentGni Co., Ltd.accessdata.fda.gov
June 4, 2012K120471MACH BRACKETS BRIGHT BRACKETSNJMSubstantially EquivalentWorld Bio Tech Co., Ltd.accessdata.fda.gov
December 4, 2007K072830RM BOND, MODEL J032DYHSubstantially EquivalentPentron Clinical Technologiesaccessdata.fda.gov
November 1, 2005K052370CP BRACKET SYSTEMDYWSubstantially EquivalentDentsply Internationalaccessdata.fda.gov
February 24, 2004K033767DUAL TOP ANCHOR SYSTEM SCREWSDZESubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
May 9, 2003K030743ETCHANT 40%KLESubstantially EquivalentConfi-Dental Products Co.accessdata.fda.gov
November 28, 2000K002991ZAP DUAL CURING LIGHTEBZSubstantially EquivalentSoft-Core Texas, Inc.accessdata.fda.gov
February 11, 2000K993224T-GEAR, MODEL TG/400-700DZBSubstantially EquivalentDontech Products B.V.accessdata.fda.gov
October 29, 1996K963205ALGINMAX, ORTHOCHROMEELWSubstantially EquivalentAmerican Tooth Industriesaccessdata.fda.gov
March 8, 1995K950121FRANCE ORTHODONTIEDZBSubstantially EquivalentFrance Orthodontieaccessdata.fda.gov

Compare with other makers

Updated November 15, 2019. 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.