Registered with FDA
Plasdent Corporation
Pomona, CA, United States. Lists 19 dental device types with FDA across 1 registered establishment.
- Device types listed
- 19
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 414 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Plasdent Corporation 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 | Plasdent Corporation | 19 device types | — | Below |
| Colombia | INVIMA | Registration holder | PLASDENT CORPORATION | 10 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Plasdent Corporation | 2 | 2017–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | PLASDENT CO.Plasdent Corporation | 2 | — | 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 Plasdent Corporation 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 | MOUTHPIECE, SALIVA EJECTOR, PLASTIC TUBES, ASPIRATOR TIPS | 1994 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | DENTAL NEEDLE TIPS, BENT NEEDLE TIPS, IRRIGATION NEEDLE TIPS | 2016 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Dental Mirror, Mouth Mirror, Photography Mirror, Photo Contrastor | 2011 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | IMPRESSION TRAY,RESIN,BITE TRAY,IMPRESSION TRAY MATERIAL | 2011 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | UNIT,SYRINGE,AIR AND/OR WATER-SYRINGE COVERS, TIP COVERS | 2011 |
| Roll CottonEFN · Class 1 | — | Lister | Cotton Rolls, cotton roll dispenser, cotton roll applicators | 2021 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | Denture Cleanser | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | PLASTIC BRUSHES, PLASTIC APPLICATORSTOOTHBRUSH, MANUAL-MICRO BRUSH, MINI BRUSH | 2011 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Plastic Film Holder,Bite Block,Film carrier,Barrier envelopes, Aligning system,Snap film holder,Sensor holder,Film Mount | 2014 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Preformed Impression Trays | 2025 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, HVE Tip Accessories, Adaptors | 2011 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Plastic Impression Syringes, Plastic injectors, Material Carrier, Syringe Tips, Mixing & Intraoral tips, Dispenser Guns | 1998 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Cheek Retractors, Props, Retractor-all types | 2016 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | Valve, Snap on tips, Lever, SE Tip Accessories | 2014 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Dental Floss | 2014 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Lister | Pick, Soft Picks, Toothpicks,Plastic Wedges | 2015 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | Tray Paper, Bib, Tissue Headrest Cover, Face & Chest Cover | 2011 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | Dam frame,overglove,Barrier apron,Waste bag,Inserts,Capsule applier,Brush handle& tips,Finger ruler,Matrix,Splash shieldDENTAL ACCESSORIES,Oral cup,Water Bottle,Vacuum Canister,Mixing Tip,Plastic Boxes,Matrices,Aligner Seater,ConnectorFoam insert,Cartridge connector,Syringe tips,Intraoral tip,Plug,Core Forms,Polishing item,Tube&Plug,Indicator tape&stripTraps,Wraps, Model cartridge,Model Former, Mixing well, Pouch, Dappen dishes, Plastic sterilization tubing, Spatula,Bowl | 2011 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | Chair, Chair stools & accessories, plastic covers, plastic tubing & sleeves, barrier films, plastic bags | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PLASDENT CORP.FDA reg. 2029234 | POMONA, CA, United States | Complaint file establishment, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9010801). 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.