Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003491259

FEI Number

3003491259

Entity Name

ERSKINE DENTAL

City/State/Country

MACKSVILLE New South Wales, AU

Establishment Address

5-9 Kylie Street, MACKSVILLE New South Wales 2447, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Erskine Dental (Owner Number: 9079903)

Owner / Operator Contact Address

5-9 KYLIE STREET, --, MACKSVILLE, NSW, AU-NSW 2447, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JES	Floss, Dental	Dental	Class 1	872.6390	2010-03-22
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-12-17
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2016-04-20
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2017-08-23
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2005-11-23
JET	Pick, Massaging	Dental	Class 1	872.6650	2025-09-03
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2017-10-25
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2012-03-20
KXR	Applicator, Resin	Dental	Class 1	872.3140	2010-03-22

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: FDABasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Erskine Dental

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

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3014045831	DENTAL LACE INC.	Pittsfield, ME, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003491259. Last updated year: 2026. Please use registration number 3003491259 when referencing this establishment in official correspondence.