Manufacturer registered with FDA

Inteware Co., Ltd

Chiayi County, Taiwan. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10056771Manufacturer

Device types listed: 2
Brands and models: 3
510(k) clearances: 12019–2019
Markets registered in: 1United States
Establishments: 1Taiwan

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Inteware Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2	Intraoral scanners	Maker	AirDesignEZCAD	2018
Orthodontic SoftwarePNN · Class 2	Dental design & orthodontic software	Maker	OrthoAnalysis Software	2019

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 Inteware Co., Ltd as the applicant.

Decided	510(k)	Device	Device type
12 Sep 2019	K183695	OrthoAnalysis Software	PNN Orthodontic Software

Registered establishments

Establishment	Location	What it does
INTEWARE CO., LTDFDA reg. 3013912897	Chiayi County Chiayi(County), Taiwan	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10056771). 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.