Not currently registered with FDA under this name

Dentist IN A Box Pty., Ltd.

Malvern, Victoria, Australia. Named as applicant on 1 dental 510(k) clearance between 2012 and 2012. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12012–2012
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Dentist IN A Box Pty., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: AustraliaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Dentist IN A Box Pty., Ltd.	1 clearances	2012–2012	Below
Australia	TGA	Manufacturer	Dentist In A Box Pty Ltd	1	2006–2006	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

510(k) clearances

Clearances on which FDA names Dentist IN A Box Pty., Ltd. as the applicant.

Decided	510(k)	Device	Device type
12 Jun 2012	K120695	DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT	EMB Zinc Oxide Eugenol

Sources

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 of the most recent filing, which can be a US agent.