Data / Medical devices / United States / Orthoselect

Orthoselect: FDA-registered device maker in American Fork, UT, United States, 1 510(k) clearance

Name: Orthoselect FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Orthoselect is registered with the FDA (registration 3010111497) in American Fork, UT, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 21, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010111497
Address: 772 E Utah Valley Dr Ste 100, American Fork, UT, United States, 84003
Owner or operator: OrthoSelect (10091189)
Roles: Manufacturer
First device listed: July 19, 2024
Registered through: 2026
Brand names listed: DIBS AI, DIBS AI Indirect Bonding Tray

Devices it lists

Device	Product code	Class	Role	Source
Indirect Bonding Tray	QJJ	1	Manufacturer	accessdata.fda.gov
Orthodontic Software	PNN	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 21, 2020	K192701	DIBS (Digital Indirect Bonding System)	PNN	Substantially Equivalent	Orthoselect, LLC	accessdata.fda.gov

Compare with other makers

Updated April 21, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.