Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010111497

FEI Number

3010111497

Entity Name

ORTHOSELECT

City/State/Country

American Fork, UT, US

Establishment Address

772 E Utah Valley Dr Ste 100, American Fork, UT 84003, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OrthoSelect (Owner Number: 10091189)

Owner / Operator Contact Address

831 E 340 S, Suite 170, Suite 170, American Fork, UT 84003, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192701

PMA Number

N/A

All Registered Proprietary Names

DIBS AI Indirect Bonding Tray DIBS AI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2024-12-18
PNN	Orthodontic Software	Dental	Class 2	872.5470	2024-07-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-07-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OrthoSelect

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3015341209	ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO.,LTD	Jiaxing City Zhejiang, CN
3014680794	JOHNS DENTAL LABORATORY	Terre Haute, IN, US
3008261720	JJGC Industria e Comercio de Materiais Dentarios SA	Curitiba Parana, BR
3005695824	Align Technology de Costa Rica S.R.L	Belen Heredia, CR
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010111497. Last updated year: 2026. Please use registration number 3010111497 when referencing this establishment in official correspondence.