Manufacturer registered with FDA

OrthoSelect

American Fork, UT, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10091189Manufacturer

Device types listed: 2
Brands and models: 2
510(k) clearances: 12020–2020
Markets registered in: 3147 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name OrthoSelect as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	OrthoSelect	1 clearances	2020–2020	Below
Saudi Arabia	SFDA	Manufacturer	ORTHO SELECT GmbH	140	—	Pure Global AI
Colombia	INVIMA	Registration holder	ORTHO SELECT GMBH	7	—	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

Devices listed with FDA

What OrthoSelect 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	DIBS AI	2024
Indirect Bonding TrayQJJ · Class 1	—	Maker	DIBS AI Indirect Bonding Tray	2024

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 OrthoSelect as the applicant.

Decided	510(k)	Device	Device type
21 Apr 2020	K192701	DIBS (Digital Indirect Bonding System)	PNN Orthodontic Software

Registered establishments

Establishment	Location	What it does
ORTHOSELECTFDA reg. 3010111497	American Fork, UT, United States	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10091189). 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.