Manufacturer registered with FDA

3D Diagnostix inc

Allston, MA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10049937ManufacturerRepacker / relabelerSpecification developer

Device types listed: 3
Brands and models: 6
510(k) clearances: 12020–2020
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What 3D Diagnostix inc currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	3DDX AOX Kit3DDX Drills3DDX Fixation Pins3DDX Keys3DDX Surgical Guide3DDX Tissue Punch	2015
Sequential AlignerNXC · Class 2	Clear aligners	Maker	—	2022
Fixture Mount KitNYE · Class 1	Implant instruments & surgical kits	Maker	—	2015

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names 3D Diagnostix inc as the applicant.

Decided	510(k)	Device	Device type
22 Dec 2020	K200908	iSMILE	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
3D DIAGNOSTIX INCFDA reg. 3011429437	Allston, MA, United States	Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10049937). 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.