Manufacturer registered with FDA
Erskine Dental
MACKSVILLE, NSW, Australia. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Australia
Devices listed with FDA
What Erskine Dental currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | — | 2025 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | HydropikHydropik MiniHydropik ProHydropik Ultra | 2024 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Oral Appliance Cleaning Tablets | 2017 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Curvie Focus ToothbrushCurvie Ortho ToothbrushCurvie ToohbrushPiksters BambooPiksters Interdental Brushes | 2005 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Piksters Wax for Orthodontics & Braces | 2016 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Superdaps, Plastic Dappen Dish, Mixing Well, Brush Holder | 2020 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Master WedgePiksters Interdental Brush Gap Sizing Probe | 2017 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Power Pikster | 2017 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss-PicksSupaGRIPX-FlossX-RibbonX-Threaders | 2010 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Interpik | 2025 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Preeben | 2010 |
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 |
|---|---|---|
| ERSKINE DENTALFDA reg. 3003491259 | MACKSVILLE New South Wales, Australia | Foreign exporter, Manufacturer, Private-label distributor, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9079903). 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.