Dental Device Guide
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Manufacturer registered with FDA

Rmo, Inc.

Franklin, IN, United States. Lists 34 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10078580ManufacturerRepacker / relabelerSpecification developer
Device types listed
34
Brands and models
40
510(k) clearances
11990–1990
Markets registered in
43 registrations outside the US
Establishments
1United States
1990: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 4 markets

Where regulators' registries name Rmo, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 34 device types listedIsrael: 1 registrationsPeru: 1 registrationsTaiwan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRmo, Inc.1 clearances1990–1990Below
IsraelAMARManufacturerRMO, INC1—Pure Global AI
PeruDIGEMIDManufacturerRMO12026–2026Pure Global AI
TaiwanTFDAManufacturerRMO12026–2026Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Rmo, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Extraoral HeadgearDZB · Class 2Retainers, expanders & headgearLister
Orthopedic Face MaskSpring Gear/Safety Headgear; Facebow Penta-form;
2020
Orthodontic Ceramic BracketNJM · Class 2Orthodontic bracketsLister
Fli Clear MFLI CSL; Signature ceramic bracket
2020
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2—Lister
Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock
2020
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearMaker
Quad Helix, Multi-Action Appliance, Palatal Appliance, AdapterRapid palatal expanderZero Corrector
2020
Saliva Ejector MouthpieceDYN · Class 1—Lister
RMO Mouthgaurd
2020
Orthodontic Material BandDYO · Class 1Orthodontic wires & bandsMaker
Truform
2020
Orthodontic Space Preformed MaintainerDYT · Class 1Retainers, expanders & headgearLister
RMO SeparatorsSpace Maintainer, Lingual Arch, Bimetric Arch, Preformed Lingual
2020
Orthodontic Plastic BracketDYW · Class 2Orthodontic bracketsLister
Alice Composite, Alice Composite Roth, Alice Composite Edgewise system
2020
Orthodontic WireDZC · Class 1Orthodontic wires & bandsMaker
Bendaloy Titanium, Niti Coil Spring; Elgiloy; FLI Copper and FLI Aesthetic; Orthonol, Thermaloy PlusThermaloy Nickel Titanium Wire; RMLocks, Hooks, Other Accessories; SWLRF Wires; TRU-CHROME Stainless Steel
2020
Orthodontic TubeDZD · Class 1Orthodontic wires & bandsMaker
Orthodontic Tubes
2020
Root-Form Endosseous ImplantDZE · Class 2Dental implantsLister
Dual Top
2020
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsLister
Bond Placement Tweezer / band and bracket removers; Cutters; Wire bending pliers
2020
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister
Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock
2020
Ultraviolet Activator for PolymerizationEBZ · Class 2Curing lightsLister
Flashmax P4 Light Curing Pen and Flashmax Accessories
2023
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsLister
ELASTIC SEPARATORS; Elastic Thread; Elastics; Energy Chain; RMO ELASTOMERIC LIGATURES; Rotation Wedge
2020
Orthodontic Preformed BandECM · Class 1Orthodontic wires & bandsMaker
Truform
2020
Orthodontic SpringECO · Class 1Orthodontic wires & bandsMaker
Elgiloy coil spring; Orthonol coil spring
2020
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsLister
Schweickhardt/Apex Series Ligating pliers / ligature removal / ligature director/Tucker
2020
Orthodontic Band PusherECS · Class 1Dental hand instrumentsLister
Schweickhardt Band Pusher
2020
Orthodontic Band DriverECT · Class 1Dental hand instrumentsMaker
Schweickhardt band adapter/SEATERS
2020
Intraoral Dental WaxEGD · Class 1—Lister
Patient Relief Wax
2023
X-Ray Film HolderEGZ · Class 1—Lister
FITZGERALD X-RAY HOLDING UNIT
2020
Preformed ClaspEHP · Class 1—Maker
Preformed wire clasp; RM Ball Retainer Clasp, Adams Clasp, J Clasp, Hawley Wire
2020
Preformed Impression TrayEHY · Class 1Impression traysLister
RMO Impression Tray
2020
All Types RetractorEIG · Class 1Dental hand instrumentsLister
Cheek Retractor
2020
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsMaker
FLI mini;FLI Twin;Integra;Mini-Taurus;Alexander;Synergy;Synergy fx;Alpine SL;Mini Low Profile;Altitude SL;Mesh Base
2020
Alloy Other Noble MetalEJS · Class 2Dental alloysLister
Bridging wire; Silver Solder
2020
Operative Cutting InstrumentEKD · Class 1Dental hand instrumentsLister
Schweickhardt/Apex cutter
2020
Impression MaterialELW · Class 2Impression materialsLister
Ortho-Jel Alginate
2020
Orthodontic PlierJEX · Class 1Dental hand instrumentsLister
Schweickhardt/Apex Series Pliers
2020
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister
TruLock Conditioner
2020
Preformed Tooth PositionerKMY · Class 1Retainers, expanders & headgearLister
Kussick Orthopedic Incline; Kussick Tongue Retrainer
2020
Resin ApplicatorKXR · Class 1—Lister
TruLock BRUSH and Sticks
2020
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsLister
Dual Top and Orthonia endosseous dental implant tools
2020

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

510(k) clearances

Clearances on which FDA names Rmo, Inc. as the applicant.

Decided510(k)DeviceDevice type
3 Aug 1990K902050BIOLASTIC SUPER ELASTIC ARCHESEJF Orthodontic Metal Bracket

Also lists devices cleared under other names

Rmo, Inc. 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: GNI Co., LTD (1), World Bio Tech Co Ltd (1), Pentron Clinical Technologies (1), Dentsply International, Inc. (1), Jeil Medical Corporation (1), Confi-Dental Products Co. (1), Soft-Core Texas, Inc. (1), Dontech Products B.V. (1).

Decided510(k)DeviceApplicantDevice type
15 Nov 2019K182672ROSA BracketGNI Co., LTDNJM Orthodontic Ceramic Bracket
4 Jun 2012K120471MACH BRACKETS BRIGHT BRACKETSWorld Bio Tech Co LtdNJM Orthodontic Ceramic Bracket
4 Dec 2007K072830RM BOND, MODEL J032Pentron Clinical TechnologiesDYH Resin Bracket and Tooth Conditioner Adhesive
1 Nov 2005K052370CP BRACKET SYSTEMDentsply International, Inc.DYW Orthodontic Plastic Bracket
24 Feb 2004K033767DUAL TOP ANCHOR SYSTEM SCREWSJeil Medical CorporationDZE Root-Form Endosseous Implant
9 May 2003K030743ETCHANT 40%Confi-Dental Products Co.KLE Resin Tooth Bonding Agent
28 Nov 2000K002991ZAP DUAL CURING LIGHTSoft-Core Texas, Inc.EBZ Ultraviolet Activator for Polymerization
11 Feb 2000K993224T-GEAR, MODEL TG/400-700Dontech Products B.V.DZB Orthodontic Extraoral Headgear
29 Oct 1996K963205ALGINMAX, ORTHOCHROMEAmerican Tooth IndustriesELW Impression Material
8 Mar 1995K950121FRANCE ORTHODONTIEFrance OrthodontieDZB Orthodontic Extraoral Headgear

Registered establishments

EstablishmentLocationWhat it does
RMOFDA reg. 1718476Franklin, IN, United StatesManufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10078580). 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.