Manufacturer registered with FDA
American Orthodontics
Sheboygan, WI, United States. Lists 34 dental device types with FDA across 1 registered establishment, and holds 44 510(k) clearances as applicant.
- Device types listed
- 34
- Brands and models
- 213
- 510(k) clearances
- 441989–2026
- Markets registered in
- 653 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 6 markets
Where regulators' registries name American Orthodontics 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 | American Orthodontics | 44 clearances | 1989–2026 | Below |
| Brazil | ANVISA | Manufacturer | AMERICAN ORTHODONTICS CORPORATIONAMERICAN ORTHODONTICS | 27 | 2012–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | American Orthodontics | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | AMERICAN ORTHODONTICS | 8 | 2018–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AMERICAN ORTHODONTICS | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AMERICAN ORTHODONTICS | 4 | 2005–2020 | 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 American Orthodontics currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | BracePasteBracepaste - Color ChangeBracePaste Band And Build LCBracePaste Fluoride SealantBracePaste Prime PlusEagle FluorSureEagle No DriftEagle SpectrumMR Lock LCNo Mix: 30 1 morePorcelain Conditioner | 2007 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | DiastemaEmpower 2Forever GoldForever Gold 24KIconixLP Low ProfileMaster SeriesMetal Custom RxMini Master SeriesMini Standard Edgewise 6 moreMini TweedSLStainless Steel BracketStealth LingualT320/40 Ceramic Brackets (Roth, McLaughlin-Bennett-Trevisi (MBT), Standard Edgewise) | 1992 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Acid EtchantBracePaste MTP Light Cure PrimerBracePaste Prime Plus | 2018 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | CleoEmpower Clear®, Empower® 2 ClearRadiance Plus® | 2013 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Lister | EAGLEWEAR;Protraction Face Mask | 2020 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Impressa/ChromeImpressa/Sure | 2011 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Bandtite Band CementBandtite Glass Ionomer Cement | 2007 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Alexander Lip BumperCantilever Bar OffsetDistal JetGentle JumperHanks Telescoping Herbst®Herbst ApplianceIntraoral Expansion ScrewsIOA Inter Occlusal ApplianceJasper JumperJones Jig 18 moreJones Jig (re-order components)Lip BumperLip Bumper Reorder ComponentsM.A.P. Mini Activator PosturerMandibular AdvancerMesial JetMiniscope Telescoping Herbst®Palatal ArchesPowerBarPowerscope 2Quad HelixQuick FixQuick Fix (re-order components)Rapid Molar IntruderRapid Molar Intruder (re-order components)Spring Jet Spring Jet 1, Spring Jet 2Uprighter JetYC3 Shield / Muh Shield | 1993 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Lister | Band Material | 1992 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Bite BlocksBondable RetainerBondable Space MaintainerTongue Director | 1992 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | Silkon Plus | 2007 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Ball Retainer ClaspsBeta Titanium WireEverwhite WireForce Two NiTi WireIconixKobayashi HooksLigature WireMultiphase Blue Chromium Cobalt WireNT3Orientation Pin 12 morePower PinStainless Steel Multi-StrandStainless Steel Retainer WireStainless Steel WireSuperelastic Titanium MemoryTanzoTanzo TriForceTherma-TiTherma-Ti "D"Therma-Ti LiteTritaniumWrap Around Hawley Retainer | 1992 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Convertible DoubleConvertible SingelConvertible TripleCross TubesDB Tube GoldDr. Korn TubeEmpowerEmpower 2Funneled EntranceIconix 13 moreiFitInconelLP Low ProfileMaster SeriesMini Master SeriesNola Buccal TubeNon ConvertibleNon Convertible DoubleNon Convertible Lip BumperNon Convertible TripleNon Convertible WRAPAROUNDPIggyback TubesSlim Tube | 1992 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | AO Instruments - Open/CloserAO Instruments - Scaler, Band PusherBand Slitting InstrumentBracket & Band Placing Instrument (Band Pusher)Bracket & Band Placing Instrument (Direct Bond Bracket Holders, Band Seater)Bracket & Band Placing Instrument (High Heat Bite Stick, Tweezers)Empower InstrumentHex Head DriverLuno (Debond)Specialty Instruments (Adhesive Remover) 5 moreSpecialty Instruments (Band Seater/Cement Scaler)Specialty Instruments (Bracket Placement Guide)Specialty Instruments (Convertible Cap Remover, Spatula)Specialty Instruments (Mouth Mirror)Specialty Instruments (Wire Cutter) | 2013 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Photographic Mirror | 2013 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Acid Etching (Gel, Semi-Gel, Liquid) | 2013 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Blue Ray 3 | 2015 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Arch Wire SleeveClear Rotation WedgesColored ChainE-Z Tie TubingElastic PlacersLigaturesMemory ChainPlastic TieSea Life ElasticsSeparators 3 moreTextured ThreadThe Wildlife SeriesTubing | 1992 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | AnteriorsContouredMini Skirt CrownsMRMR1MR2MRX BandsRollo Bands | 1992 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Arch HookArch LockAuxillary HookBall HookBall HooksButtonsCeramic ButtonCoil EyeletCrimpable StopElastic Lugs 11 moreEruption ApplianceEyeletsGull Wing CleatsLingual SheathsLow Profile CleatsMonkey HookPower HookSeating LugsSurgical HookUT HookWeldable Stop | 2001 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | ART® Auxiliary SpringAuxiliary Light Torquing ArchCompliance SpringKilroy SpringNickel Titanium Memory SpringsNiTi SpringsRotation SpringSeparating SpringStainless Steel SpringsUlysses/Extrusion Spring 2 moreUprighting SpringWarren | 1992 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Ligating Instruments (Mathieu Needle Holder, Smaha Forceps, Hemostat)Ligating Instruments(Ligature Director, Single End Explorer, Force Module Separator, Ligature Tying Pliers, Wire Seater) | 2013 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner Seater | 2026 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Roll Holders | 1988 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Platypus Orthodontic Toothbrush | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Debond WafersLaminated Bite WafersOrtho Wax BitesOrthodontic Wax | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Tray | 2001 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | American Cheek RetractorsClear Cheek Retractors | 2001 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Specialty Instruments (Boone Gauge)Specialty Instruments (Force Gage) | 1993 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Bur KitCarbide BurDiamond Bur | 2015 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Platypus Orthodontic Flosser | 2022 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | Luno (Cutters, Band Remover)Luno (Pliers)Wire Bending Pliers | 1992 |
| FacebowKCR · Class 1 | Articulators & facebows | Lister | 300 Series Facebows | 1988 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | atmos® material - tooth positioner, Vero | 1993 |
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 American Orthodontics as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jun 2026 | K261840 | BracePaste Prime Plus | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 27 Aug 2024 | K242537 | BracePaste Fluoride Sealant | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 7 Jul 2023 | K232011 | Cleo | NJM Orthodontic Ceramic Bracket |
| 14 Aug 2020 | K202276 | BracePaste Band and Build LC | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 15 Oct 2018 | K181910 | BracePaste MTP Light Cure Primer | KLE Resin Tooth Bonding Agent |
| 6 Feb 2018 | K172953 | Acid Etchant | KLE Resin Tooth Bonding Agent |
| 14 Oct 2016 | K160782 | BracePaste Adhesive | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 14 Dec 2012 | K122753 | EMPOWER CLEAR | NJM Orthodontic Ceramic Bracket |
| 4 Aug 2008 | K080749 | RADIANCE | NJM Orthodontic Ceramic Bracket |
| 13 Sep 1993 | K925012 | PLASTIC CHAIN | EJF Orthodontic Metal Bracket |
| 31 Mar 1993 | K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | ECI Orthodontic Elastic Band |
| 31 Mar 1993 | K922984 | ORTHODONTIC BITE | LRK Anti-Snoring Device |
| 3 Dec 1992 | K923261 | ORTHODONTIC METAL BRACKET | EJF Orthodontic Metal Bracket |
| 20 Dec 1991 | K912417 | MOLAR DISTALIZING ASSEMBLY | DYJ Orthodontic Screw Expansion Retainer |
| 9 Nov 1990 | K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | KMY Preformed Tooth Positioner |
| 6 Aug 1990 | K902064 | MODIFIED UNI-STICK PLASTIC LIGATURE | EJF Orthodontic Metal Bracket |
| 1 Jun 1990 | K900488 | MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE | EJF Orthodontic Metal Bracket |
| 26 Jan 1990 | K896249 | BANDTITE GLASS IONOMER CEMENT | EMA Dental Cement |
| 21 Dec 1989 | K895714 | ORTHO-KEV APPLIANCE REINFORCING SYSTEM | EBI Rebasing Repairing Relining Denture Resin |
| 27 Oct 1989 | K895163 | FORCE II | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 16 Oct 1989 | K891331 | UNI-STICK PLASTIC LIGATURES | EJF Orthodontic Metal Bracket |
| 12 Oct 1989 | K893482 | KORN MANDIBULAR ADVANCER | EJF Orthodontic Metal Bracket |
| 23 Aug 1989 | K893655 | KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK | EJF Orthodontic Metal Bracket |
| 14 Jul 1989 | K893555 | X-RING AND SPEED STIX PLASTIC LIGATURES | EJF Orthodontic Metal Bracket |
| 14 Jul 1989 | K893550 | PLASTIC FORCE MODULE | EJF Orthodontic Metal Bracket |
| 14 Jul 1989 | K893484 | MULTIPHASE ORTHODONTIC WIRE | EJF Orthodontic Metal Bracket |
| 14 Jul 1989 | K893483 | BONDABLE RETAINER AND SPACE MAINTAINER | EJF Orthodontic Metal Bracket |
| 23 Jun 1989 | K893654 | MEMORY CHAIN | EJF Orthodontic Metal Bracket |
| 23 Jun 1989 | K893549 | X-RING SEPARATORS | EJF Orthodontic Metal Bracket |
| 23 Jun 1989 | K893542 | DIASTEMA CLOSING KIT | EJF Orthodontic Metal Bracket |
| 23 Jun 1989 | K893396 | AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 21 Jun 1989 | K893255 | SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 12 Jun 1989 | K893037 | NO-MIX 30 ORTHODONTIC BONDING SYSTEMS | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 11 May 1989 | K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES | EJF Orthodontic Metal Bracket |
| 2 May 1989 | K891599 | FILAFLEX ORTHODONTIC WIRE | EJF Orthodontic Metal Bracket |
| 1 May 1989 | K890536 | JASPER JUMPER KIT | EJF Orthodontic Metal Bracket |
| 17 Apr 1989 | K891354 | ORTHODONTIC COTTON ROLL HOLDERS | KHR Paper Saliva Absorber |
| 17 Apr 1989 | K890656 | LIP BUMPER | EJF Orthodontic Metal Bracket |
| 14 Apr 1989 | K891484 | ORTHODONTIC WRAP-AROUND HAWLEY RETAINER | EJF Orthodontic Metal Bracket |
| 7 Apr 1989 | K891592 | ORTHODONTIC ARCH AND SURGICAL HOOKS | EJF Orthodontic Metal Bracket |
| 31 Mar 1989 | K891372 | ORTHODONTIC PLASTIC BRACKET | DYW Orthodontic Plastic Bracket |
| 31 Mar 1989 | K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER | KMY Preformed Tooth Positioner |
| 17 Mar 1989 | K890581 | THE CLARK LIP SHIELD | EJF Orthodontic Metal Bracket |
| 13 Mar 1989 | K890145 | 20/20 ORTHODONTIC CERAMIC BRACKET | EJF Orthodontic Metal Bracket |
Also lists devices cleared under other names
American Orthodontics 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: Scientific Pharmaceuticals (4), Lascod Spa (1), Satelec (1), Ortho Technology, Inc. (1), American Tooth Industries (1), GC America Inc. (1), Ortho Kinetics Corp. (1), Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Aug 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | Lascod Spa | ELW Impression Material |
| 21 Oct 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 21 Jul 2000 | K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | Scientific Pharmaceuticals | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 9 Jun 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology, Inc. | DZB Orthodontic Extraoral Headgear |
| 29 Oct 1996 | K963205 | ALGINMAX, ORTHOCHROME | American Tooth Industries | ELW Impression Material |
| 24 May 1996 | K961417 | GC FUJI ORTHO | GC America Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 10 Mar 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 30 Jul 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corporation | EJF Orthodontic Metal Bracket |
| 16 Apr 1990 | K895386 | GLASION | Scientific Pharmaceuticals | EMA Dental Cement |
| 21 Jul 1987 | K872569 | TEMREX ETCHING GEL | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 18 Jul 1983 | K831495 | CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO | Scientific Pharmaceuticals | DYH Resin Bracket and Tooth Conditioner Adhesive |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AMERICAN ORTHODONTICSFDA reg. 2126683 | SHEBOYGAN, WI, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2126683). 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.