Manufacturer registered with FDA
Practicon, Inc.
Greenville, NC, United States. Lists 26 dental device types with FDA across 1 registered establishment.
- Device types listed
- 26
- Brands and models
- 92
- 510(k) clearances
- 0as applicant
- Markets registered in
- 214 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Practicon, 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 | Practicon, Inc. | 26 device types | — | Below |
| South Korea | MFDS | Manufacturer | PRACTICON, INC.Practicon, Inc. · PRACTICON INC | 14 | 2004–2005 | 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 Practicon, 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 |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Practicon 33G Dental NeedlePractiShield | 2003 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Bite DXCompo-Dot AnglesCompo-DotsDisposable Exam PacksDisposable Probe/Shepherd's HookEndoBand CushionsHAHN 360 PDL Extractor InstrumentRoetzer Posterior Packer Sculptor (PPS) Instrument | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Disposable Mouth MirrorMirror Cotton HoldersNice Touch Mouth MirrorsPracticon Classic Disposable Mouth MirrorsPracticon Fog-Free Photo Mirror KitPracticon Versagrip Mouth MirrorsPracticon Vibrant Disposable Mouth Mirrors | 2006 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Practicon Clear Disposable A/W Syringe TipsPracticon Onyx Disposable A/W Syinge TipsPracticon Rainbow Disposable A/W Syringe TipsPractiTip A-W Syringe Tips | 2011 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | PRACTICON LIGATURE TIES | 2023 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | SmileGoods Aligner ChewiesSmilegoods Aligner RemoverSmilegoods Right-Bite Aligner Seaters | 2022 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | NiceTouch ToothbrushPractivalu ToothbrushSmileGoods ToothbrushSwift Mini Brushes | 2015 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Patient Relief Wax | 2022 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | PlateMates PSP Protectors | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Disposable Edentulous TraysECOsply Biodegradable Impression TraysMicro TrayPracticon Autoclavable Impression Tray | 2011 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Angle-EaseColor Splash Saliva EjectorsColor Tip Saliva EjectorsColorFlex Saliva EjectorsDispos-Evac AspiratorsDispos-Evac HVE TipECOtip HVE TipsHVEZ Hose AdapterLock-On HVE Hose AdapterLock-On Saliva Ejector Valve 11 moreLock-on Saliva Ejector ValvesLockOn S/E Valve TipsMax-Vac Evacuator TipsMirro-VacMirro-Vac 2Multi-Tips HVE TipsPracticon Colorful HVE TipsRainbow Saliva EjectorsTotal-Comfort ColorFlex Soft Tip AspiratorsVacGuard HVE Screen TipsWhisperSafe HVE Tips | 2006 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Pike Anesthetic Syringe | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | BFC UNIT DOSE SYRINGEBFC3 Powered Impression GunHP Mixing TipsRibbon Intraoral Tips | 2016 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Lumindex 3 Barrier Sleeves | 2008 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | C Type Cheek RetractorC Type Winged Cheek RetractorLip RetractorY Type Cheek Retractor | 2007 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Lister | GP Cut Gutta Percha CutterGP Cut Replacement Tips | 2023 |
| Endodontic Stabilizing SplintELS · Class 2 | — | Maker | GlasSpan Dental Fiber | 2018 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Paraband | 2013 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Smilegoods Sonic Toothbrush | 2021 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss HandsFloss HoldersFlosSeasGiraffe FlossersIndiflossMint Floss PicksMobile FlossMobile Floss 2Rocketeer FlossersSDFLosser 3 moreSmileGoods 3-in-1 FlossersSmileGoods Dental FlossSmilegoods Floss Threaders | 2007 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | SmileGoods PikPak Interproximal Cleaners | 2017 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | Practicon Disposable Patient Bibs | 2026 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | I-Beam Fluoride Tray | 2017 |
| Tongue ScraperLCN · Class 1 | — | Maker | DualCare Disposable Tongue Cleaner and PickPlastic Tongue CleanersSmileGoods Tongue Cleaners | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dr. Shwartzs Cap Trap Retainers | 2022 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | PRACTIFILM BARRIER FILM | 2024 |
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
Practicon, 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: Glasspan, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Feb 1994 | K922673 | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. | ELS Endodontic Stabilizing Splint |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRACTICON, INC.FDA reg. 1051614 | Greenville, NC, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1051614). 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.