Manufacturer registered with FDA
Ortho Organizers, Inc.
Savannah, GA, United States. Lists 37 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 37
- Brands and models
- 396
- 510(k) clearances
- 81993–2025
- Markets registered in
- 156,567 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 15 markets
Where regulators' registries name Ortho Organizers, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ortho Organizers, Inc. | 8 clearances | 1993–2025 | Below |
| Thailand | Thai FDA | Manufacturer | ORTHO ORGANIZERS,INC.ORTHO ORGANIZERS, INC. | 5,005 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ORTHO ORGANIZERS INC. | 1,172 | 2003–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ortho Organizers, Inc. | 161 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ortho Organizers, Inc.Ortho Organizers Inc · Ortho Organizers Inc. · +2 | 61 | 1999–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ORTHO ORGANIZERS, INCORTHO ORGANIZERS INC. · ORTHO ORGANIZERS, INC. | 31 | 2002–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Ortho Organizers Inc | 28 | 2004–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHO ORGANIZERS , INC.ORTHO ORGANIZERS, INC. · Ortho Organizers, Inc. | 22 | 2005–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ortho Organizers, Inc. | 22 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | OrthoOrganizers IncOrtho Organizers Inc | 20 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ORTHO ORGANIZERS, INCORTHO ORGANIZERS INC | 17 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ORTHO ORGANIZERS, INCORTHO ORGANIZERS INC · ORTHO ORGANIZERS INC. | 17 | 2022–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ortho Organizers, Inc. | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Ortho Organizers, Inc. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 正畸整合股份有限公司Ortho Organizers, Inc. | 1 | — | Pure 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 Ortho Organizers, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | Cervical Neck PadsClassOne FacemaskClassOne Safety Release ModulesExtraoral FacebowsHigh Pull Head CapsMasel Safety Release ModulesMulti-Adjustable FacemaskProtraction FacemaskReleasable Force ModuleReverse Pull Facemask | 2007 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Aria BracketsAria ExpressionsBAND & BRACKET ASSEMBLYBionicBITE GUIDECarriere Motion 3D Class II MalocclusionCarriere Motion 3D Class III MalocclusionCarriere Motion 3D Clear Class II MalocclusionCarriere Motion 3D Colors Class II MalocclusionCarriere Motion 3D Sidekick Bondable Hook 46 moreCarriere Motion Pro Bite CorrectorCarriere Motion Pro Clear Bite CorrectorCARRIERE SELF LIGATING BRACKETCarriere SLXCarriere SLX 3DCLASSIC SERIES STAINLESS STEEL BRACKETSCLEATSDi-MIM BracketsDirect Bond ButtonsDirect Bond EyeletDirect Bond EyeletsDirect Bond Lingual ButtonDirect Bond RetainerEDGEWISE MINI-ELITE OPTI-MIM NICKEL-LITE BRACKETSElite BracketsERUPTION APPLIANCEFIXED RETAINERGold Eruption ApplianceHerbst ApplianceLC Lingual RetainerLINGUAL BARLINGUAL BUTTONSLINGUAL CLEATSLINGUAL EYELETSLINGUAL HOOKLINGUAL LUGSLINGUAL SHEATHSLotus Plus DSMaestro BracketsMasel Direct Bond Button Round Flat BaseMicro Direct Bond ButtonNickel-Free Mini TwinNITANIUM PALATAL EXPANDERNITANIUM ROTATORPinnacleReflectionsSolstice BracketsSTAINLESS STEEL LINGUAL DIRECT BONDTongue TamersTRANSFORCETruEase Bite CorrectorTruEase Rapid Palatal ExpanderTwin Force Bite CorrectorVotionWeldable ButtonsWeldable Lingual Button - Curved | 1995 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | Bite-BuilderCarriere Motion 3D Clear Class II MalocclusionCarriere Motion Pro Clear Bite CorrectorComposite Direct Bond ButtonOrthoflex Composite BracketsOrthoFlex Composite ButtonsOrthoFlex Composite Eyelet | 2007 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | Carriere SLX 3D ClearNeoCrystal PlusNeoLucent PlusPURE | 2012 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Lister | — | 2023 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Expabent Expansion ScrewExpansion ScrewsIntraoral Appliances- MultipleLombardi Bionator Bite ApplianceMedium ExpansorMicro Sectional Expansor UpperSafety Swivel KeyStandard ExpansorSuper Micro ExpansorSuper Micro Sectional Expansor 1 moreVertical Arm Expansion Screw | 2001 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Reveal® Retainers | 2022 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | ANDREWS2 ARCHWIREARCHWIRE RETAINERAUSSIE STAINLESS STEEL WIREBETA III ARCHWIRESBetaForce Beta Titanium ArchwireBIO-TWIST ARCHWIRESBLACK TI ARCHWIRESBondable Lingual RetainerBraided Retainer WireCNA ARCHWIRES 76 moreCNA BETA III ARCHWIRESCNA Palatal ArchCTA EXTRACTION ARCHWIRESCTA NON-EXTRACTION ARCHWIRESCV SUPERFORCE ARCHWIRESEcono Nickel Titanium ArchwiresECONOMY NITI ARCHWIRESEIGHT STRAND ARCHWIRESELASTINOL - ORTHOCOSMETICELASTINOL ARCHWIRESFIXED LINGUAL CONTROLLED ARCHFlat Titanium Dead-Soft Lingual RetainerKobayashi TiesKOBY LIGATURE TIESKOBY TIE HOOKSLABIAL ARCHWIRESLIGATURE TIESLigature WireM-Series ArchwiresMasel Stainless Steel Ligature WireMASILOY CHROME COBALT ARCHWIRESMDA FIXED APPLIANCEMDA WIREMICRO COATED BIO-KINETIX ARCHWIRENITANIUM ARCHWIRESNITANIUM COATED ARCHWIRESNITANIUM LOOPED ARCHWIRENITANIUM MULTIFORCE ARCHWIRENITANIUM RCS ARCHWIRENITANIUM SPOOLED ARCHWIRENITANIUM STRAIGHT WIRENitanium Torqued ArchwireNITINOL ARCHWIRESPENTA ONE ARCHWIRESPREFORMED LIGATURE TIEPREMIUM NITI ARCHWIRESRegency Confidential ArchwireREGENCY ULTRA THERM ARCHWIRERETAINER ARCHWIRESREVERSE CURVE ARCHWIREShorty Ligature TwistsSIX STRAND ARCHWIRESPOOLED ARCHWIRESTAINLESS STEEL ARCHWIRESTAINLESS STEEL BRIGHT ARCHWIRESTAINLESS STEEL COATED ARCHWIREStainless Steel Coaxial ArchwireSTAINLESS STEEL GOLD TONE ARCHWIRESTAINLESS STEEL LOOPED ARCHWIRESTAINLESS STEEL MULTI-STRAND ARCHWIRESTAINLESS STEEL MULTI-STRAND ARCHWIRE SPOOLSTAINLESS STEEL MULTI-STRAND ARCHWIRE STRAIGHTSTAINLESS STEEL POSTED WIREStainless Steel Spooled Ligature WireStainless Steel Standard Twist ArchwiresStainless Steel Straight LengthsStraight WireSUPER ELASTIC NITANIUM ARCHWIRESSUPER PLUS ARCHWIRETEMPERED SPRINGTherma-A-Form Ultra ArchwireTHREE STRAND ARCHWIRETooth Tone Coated ArchwireTooth Tone Coated Preformed Ligature TiesTooth Tone TiesTRIPPLE TWIST ARCHWIRETruFlex Copper Nickel Titanium ArchwireTruFlex Nickel Titanium ArchwireTruForce Retainer WireTruForce Stainless Steel ArchwireTruForce Stainless Steel Preformed Ligature TiesTruForce Stainless Steel Twist WireTruForce TiesUtility Archwire KitVALUE BRAND OF NITIWIRE MESH | 2005 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | BUCCAL TUBEBUCCAL TUBES AND ATTACHMENTSCrimpable Cross TubesCrimpable Double TubesELITE OPTI-MIM TUBESMaestro Buccal TubesNickle Free Direct Bond Buccal TubesORTHODONTIC BANDS, LINGUAL ATTACHMENTS AND BUCCAL TUBESTruCast Mini Second Molar Bondable Buccal TubesTruEase Bondable Buccal Tubes 1 moreTruFit 2 Buccal Tubes | 2005 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Archwire MarkersBRACKET PLACEMENT/POSITIONERCarriere SLX 3D EZ Twist Opener TweezerCarriere SLX CFI Opening ToolElastic AttacherElastic DirectorsElastic RemoverExplorerFalcon InstrumentsLotus Plus® DS SLB Turn Key 3 moreORTHODONTIC INSTRUMENTSSLB Opening ToolX7 Instruments | 2012 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MirrorPhotographic Stainless Steel MirrorsPixSure Perfect | 2009 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | BRACE COVERBulk ElasticsBULK LIGATURE TIESBumper SleeveCarriere Motion 3D Force 1 and Force 2 ElasticsCarriere Motion Force 3 ElasticsClassOne Natural ElasticsClear ElasticsCLEAR SOFT TUBINGCOMFORT COVERS 54 moreCOVER UPSElast-o-loop SeparatorsElast-o-loop2 SeparatorsElastic ChainELASTIC MINI-STICKSELASTIC SEPARATORSELASTIC STICKSElastic ThreadElastic TubeElastics AmberELASTICS LIGHT, MEDIUM, HEAVYElastics NeonELASTOMERICSEXTRAORAL ELASTICSExtreme ChainHAND-EE-LASTHollow TubingK-2 MODULEK-O MODULEKissable CoversLATEX EXTRAORAL ELASTICSLATEX FREE ELASTICS LIGHT, MEDIUM, HEAVYLATEX INTRAORAL ELASTICSLigature Rotation WedgesLigature TiesLIP BUMPER TUBINGLIP GUARDLip ProtectorMAGNUM FORCE CHAIN ELASTICMasel Elastic ChainMAXI-TIEMINI STICKSMini Unicycle Ligature TiesMini-O-TiesMINI-TIENatural ElasticsNon-Latex ElasticsO-TiesOrtho Organizers Elastic ChainOrthodontic ElasticsPatient TiesPower ChainPower SticksRadiopaque SeparatorsRainbow ElasticsRing-TiesROTATION WEDGESSafari Amber ElasticsSafari Neon ElasticsSafe-T-TiesSeparatorsTISSUE GUARDUNICYCLEWEDGES/MODULES | 1995 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | ACCUFIT BANDSAndrews2 Band AssembliesBANDSBICUSPID BANDSElite Band AssemblyEPIC BANDSMOLAR BANDSTEMPRA BANDSTruFit 2 | 2005 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Arrowhead ClaspsBall ClaspsBall HookBall Hook and StopClaspsCrimpable Archwire HooksCrimpable Archwire Power HookCrimpable Archwire StopCrimpable Archwire Tube with HookCrimpable Ball Hooks 15 moreCrimpable Bi-Directional Ball HooksCrimpable Mini StopsCrimpable Split StopsEZ Stops SystemGRIP-TIGHT LOCKHenry Schein Split Surgical Ball HookHooksMicro StopsSplit Ball HooksSplit Curved HooksSplit Rectangular Stop/HookSplit Surgical Ball Hook and StopSplit Universal Crimpable Ball HookSTOPS AND LOCKSWRENCH | 2001 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Anterior Torquing SpringCarriere® InfiNiTi LoopsClosed Coil SpringCLOSED COIL SPRINGSCLOSED SPRINGSDISTAL COIL SPRINGSDISTALIZING COIL SPRINGNickel Titanium Coil SpringsNickel Titanium Distalizing SpringsNitanium Force Springs 12 moreNitanium Open Coil SpringsOpen Coil SpringOPENING SPRINGPREFORMED COFFIN SPRINGSSEPARATING SPRINGSSEPARATORSSPRINGSSTAINLESS STEEL SEPARATING SPRINGSSTAINLESS STEEL SPRINGS/PINSTruFlex Nickel Titanium TAD Closed Coil SpringsTruFlex Separating SpringsVariable Coil Springs | 2005 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Ligature Directors | 1992 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | BOONE GAUGEBracket Placing TweezerBRACKET POSITIONER/PLACERBracketizer (multiple)Buccal Tube Bonder TweezerCarriere Motion 3D Placement InstrumentDeluxe Bracket Holder TweezerDirect Bond Bracket HolderSwivel Head Bracket Height GaugeZAND GAUGE | 2009 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Retainer Retriever | 2025 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner ChewiesBand SeaterHigh Heat Bite StickMasel Band Pusher/Seater | 2017 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | — | 2012 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | INTERPROXIMAL BRUSHORTHO KITPROXY BRUSHTOOTHBRUSH | 2009 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Elastobyte WafersLaminated Bite WafersPatient Relief WaxRelief WaferRelief WaxSilicone Patient PackUtility WaxUtility Wax Strips | 2001 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | — | 2022 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Galaxy | 2012 |
| Preformed ClaspEHP · Class 1 | — | Maker | Ball ClaspsMultiple orthodontic clasps | 2009 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | DuralockRedi-Lock | 2001 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Double Ended Lip RetractorExtraoral Cheek RetractorsHigh Heat Cheek RetractorIntraoral Cheek RetractorsMasel Cheek RetractorsOrtho Organizers Cheek RetractorsPhoto Cheek RetractorsTongue Shield | 2008 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Aluminum Height GaugeBoone GaugeBracket Height Gauge Doubled EndedHigh Heat Height Gauge | 2008 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Instrument HandleInterproximal Stripper and Blade Refill | 2012 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | GalaxyREVEAL® | 2009 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Alpha-ProAlpha-Pro Kids PackProphylaxis Paste | 2010 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | TASTES GREAT Alginate Flavoring | 2010 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | ClassOne Classic Cement Spatula and ScalerClassOne Classic Single Ended Scaler | 2018 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental FlossFlosser | 2012 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | BAND REMOVERBRACKET PLACEMENT/POSITIONERBRACKET REMOVERCarriere Double Ended Opener ToolCarriere Motion PlacerChoice Orthodontic InstrumentsDistal BenderENDURA PLUSLigature HemostatORTHODONTIC INSTRUMENTS 5 morePLASTIC NIPPERSTRIUMPH INSTRUMENTSTruEase locking toolTwin Force ToolWire Cutter, Bracket Remover-Multip | 2005 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Clear Advantage material | 2008 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Mini-Molds | 2012 |
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 Ortho Organizers, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Nov 2025 | K252760 | Carriere® Motion Pro® Clear Bite Corrector | DYW Orthodontic Plastic Bracket |
| 8 Mar 2018 | K173440 | Carriere SLX 3D Clear | NJM Orthodontic Ceramic Bracket |
| 28 Nov 2016 | K160720 | Carriere Motion Clear Class II | DYW Orthodontic Plastic Bracket |
| 19 May 2011 | K110335 | CERAMIC BRACKETS | NJM Orthodontic Ceramic Bracket |
| 31 Jul 2006 | K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | OAT Orthodontic Endosseous Implant |
| 13 Sep 1993 | K923218 | NITANIUM PALATAL EXPANDER | EJF Orthodontic Metal Bracket |
| 1 Sep 1993 | K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | DYO Orthodontic Material Band |
| 8 Jul 1993 | K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | EJF Orthodontic Metal Bracket |
Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (4), SPT Roth Ltd. (1).
Also lists devices cleared under other names
Ortho Organizers, 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: Cdb Corporation (3), Ortho Kinetics Corp. (3), Ortho Technology, Inc. (2), Clearpath Orthodontics (1), G&H Wire Company (1), Wallace A. Erickson & Co. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Jun 2021 | K210613 | HIT Clear Aligner | Cdb Corporation | NXC Sequential Aligner |
| 5 Jan 2021 | K202857 | ClearPath Aligner | Clearpath Orthodontics | NXC Sequential Aligner |
| 18 Dec 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. | NJM Orthodontic Ceramic Bracket |
| 9 Jun 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology, Inc. | DZB Orthodontic Extraoral Headgear |
| 6 Apr 1998 | K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 11 Mar 1998 | K980195 | FACEBOW | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 21 Nov 1997 | K973776 | REFLECTIONS | Cdb Corporation | DYW Orthodontic Plastic Bracket |
| 10 Jul 1996 | K961754 | SAFETY RELEASE MODULE | G&H Wire Company | DZB Orthodontic Extraoral Headgear |
| 10 Mar 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 25 Feb 1994 | K940120 | ALPHA-DENT | Wallace A. Erickson & Co. | ELW Impression Material |
| 30 Jul 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corporation | EJF Orthodontic Metal Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHO ORGANIZERS, INC.FDA reg. 2081322 | Savannah, GA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2081322). 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.