Registered with FDA
Ortho Arch Company Inc
Schaumburg, IL, United States. Lists 27 dental device types with FDA across 1 registered establishment.
- Device types listed
- 27
- Brands and models
- 58
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7344 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name Ortho Arch Company 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 | Lister | Ortho Arch Company Inc | 27 device types | — | Below |
| Canada | Health Canada | Registration holder | ORTHO ARCH COMPANY INC. | 307 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Ortho Arch Company Inc | 27 | 2018–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ORTHO ARCH COMPANY | 4 | 2018–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ortho Arch Company | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Ortho ArchOrtho Arch Company Inc | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ORTHO ARCH COMPANY INC | 2 | 2022–2023 | 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 Arch Company 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Cottonmouth Dry Field System | 2018 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Lister | COMPOSITE DIRECT BOND BUTTON | 2017 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | AJ Wilcock Australian Wire 25" Spool and 14" Length WireBeta TitaniumBlack Satin SE NitiBrehm Niti Utility ArchD2 ApplianceHA Niti FinishingHA Niti with CopperHeat Activated NitiMulti Modulus (Multi-Force) HA NitiNano Coated Super Elastic Nitinol Archwires 9 morePerformed Ligature Wire, Toothtone Ligature Wire, Shorty Ligature Ties, Kobyashi Tie HooksPosted SS Archwire, SS Cuspid-Loop Retraction Arch, AJ Wilcock Vertical-Loop Retraction ArchPre-Torqued SE NitiReverse Curve of Spee SE Niti and RSC (Straight Leg) SE NitiSE Nitinol WireShorty Kobyashi HooksSS Nic-O-Loy Keyhole 4-Loop Retraction Arch, SS T-Loop Retraction Arch, Beta-Titanium Mushroom-Loop Retraction ArchStainless Steel, SS Multi-Stranded Leveling, SS Keyhole 2-Loop Retraction Arch, SS Keyhople 4-Loop Retraction ArchTurbo-8 Braid SE Niti | 2017 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Buccal Tubes | 2017 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Elastic Attachers, Band Pusher, Band Seater | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Patient Care Kits Disposable MirrorsSuper Glass Mirror: Occlusal, Lingual and Buccal | 2017 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Fusion Curing LightREDI SET LED LIGHT | 2017 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | Amber Interoral Elastics, Rainbow Interoral Elastics, Non-Latex Clear Interoral ElasticsElastomeric Tissue Guard, Elastomeric Thread & Tubing, Rotation WedgesGlide-Ties, Elastic Chains, Elastomeric Separators | 2017 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | Composite Direct Bond ButtonCrimpable Hook CoatedLingual Sheaths, Lingual Cleats (Weldable and Direct Bond) | 2017 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | Constant Force Nitinol SpringGTS Springs | 2017 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Lister | Pin & Ligature Cutter, Mini Ligature Cutter | 2017 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | Reverse Action Keat Molar Tube PlacerVanish Twin, Vanish SLB | 2017 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Patient Care Kits, Travel Toothbrush, Disposable Toothbrush | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Patient Care Kits Patient Relief WaxPatient Relief Wax | 2017 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | Aligner Scissors | 2026 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Photo Lip Retractor, Double Ended Lip Retractor, Expando Cheek Retractor, Access Cheek Retractor, Lip Retractor | 2019 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | IPR | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Composite Direct Bond ButtonConlinHorizon TwinMicro TwinNustar Self Ligating | 2009 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Root Canal Files | 2024 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | EZ Out Elevators | 2017 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Lister | Arch Markers | 2017 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Patient Care Kits, Floss | 2017 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | SLB Easy Opening Instrument | 2017 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | Sport Mouthguard | 2019 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Mini-Molds | 2017 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | Nova C, Nova S | 2017 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Lister | Patient Care Kits | 2017 |
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 Arch Company 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: Progressive Technology, Inc. (1), Dentlight, Inc. (1), Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 May 2015 | K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. | NJM Orthodontic Ceramic Bracket |
| 28 Sep 2005 | K052593 | FUSION CURING LIGHT | Dentlight, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 21 Nov 1997 | K973776 | REFLECTIONS | Cdb Corporation | DYW Orthodontic Plastic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHO ARCH COMPANY INCFDA reg. 3007284437 | Schaumburg, IL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030081). 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.