FDA Registration
Active
🇦🇺 Australia
ERSKINE DENTAL
Reg #: 3003491259
·
FEI: 3003491259
·
Expires 2026
Products
12
Proprietary Names
23
Establishment Types
4
Classifications
12
Registration Details
- Registration Name
- ERSKINE DENTAL
- Registration Number
- 3003491259
- FEI Number
- 3003491259
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5-9 Kylie Street
- City
- MACKSVILLE New South Wales
- Country
- AU
Owner / Operator
- Firm Name
- Erskine Dental
- Operator Number
- 9079903
- Address
- 5-9 KYLIE STREET, --
- City
- MACKSVILLE, NSW
- State
- New South Wales
- Postal Code
- 2447
- Country
- AU
US Agent
- Business Name
- FDABasics LLC
- Contact Name
- Jerry Doane
- Address
- 15815 Sw 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Floss, Dental | JES | Class 1 | Dental | No | 2010-03-22 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-12-17 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2016-04-20 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2017-08-23 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2005-11-23 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2025-09-03 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2017-10-25 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2012-03-20 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2010-03-22 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2025-05-15 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2020-07-15 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2017-10-23 |
Proprietary Names
X-Ribbon
Floss-Picks
SupaGRIP
X-Floss
X-Threaders
Hydropik
Hydropik Ultra
Hydropik Pro
Hydropik Mini
Piksters Wax for Orthodontics & Braces
Oral Appliance Cleaning Tablets
Curvie Toohbrush
Piksters Bamboo
Piksters Interdental Brushes
Curvie Ortho Toothbrush
Curvie Focus Toothbrush
Interpik
Master Wedge
Piksters Interdental Brush Gap Sizing Probe
Foamies
Preeben
Superdaps, Plastic Dappen Dish, Mixing Well, Brush Holder
Power Pikster
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Manufacture Medical Device