Manufacturer registered with FDA

SoftSmile, Inc.

Long Island City, NY, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10086067Specification developer1 clearance in five years

Device types listed: 1
Brands and models: 1
510(k) clearances: 12021–2021
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What SoftSmile, 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
Orthodontic SoftwarePNN · Class 2	Dental design & orthodontic software	Maker	Vision	2022

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 SoftSmile, Inc. as the applicant.

Decided	510(k)	Device	Device type
21 Dec 2021	K212770	Vision	PNN Orthodontic Software

Registered establishments

Establishment	Location	What it does
SOFTSMILE, INC.FDA reg. 3024438491	Long Island City, NY, United States	Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10086067). 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.