Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005695824

FEI Number

3005695824

Entity Name

Align Technology de Costa Rica S.R.L

City/State/Country

Belen Heredia, CR

Establishment Address

San Antonio Business Park 112, Arbolito Street, Belen Heredia --, CR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Align Technology, Inc. (Owner Number: 9035576)

Owner / Operator Contact Address

410 North Scottsdale Road, Suite 1300, Tempe, AZ 85281, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Attachment Template Invisalign Cleaning System Invisalign Cleaning Crystals Invisalign Starter Kit with Cleaning Crystals Invisalign Palatal Holder Invisalign Palatal Holder with Engagement Features Invisalign Palatal Expander System Invisalign Palatal Expander with Engagement Features Invisalign Palatal Expander OrthoCAD iQ Invisalign System, Pre-Formed Attachment Systems Impression Tray Align Ltd. Impression Tray iTero Lumina Pro iTero Lumina Pro Mobile iTero Lumina Pro Wand Barrier Sleeves Invisalign System with Mandibular Advancement Precision Wings Invisalign System - Teen Package Invisalign System with Mandibular Advancement Enhanced Precision Wings 3D Treatment Planning Software - ClinCheck Pro 6 iOC Scanner iTero Element Flex iTero Element iTero Element 2 Plus iTero Element 5D Plus Lite iTero Element, Certified Pre-owned iTero HD2.9 Scanner iTero Element 2 iTero Element 2 Plus Mobile iTero HDU Scanner iTero Element Flex, Certified Pre-owned iTero Lumina Scanner Sleeve iTero Lumina iTero Element Sleeve iTero Element Scanner Sleeve (LCI Configuration) iTero Lumina Mobile lnvisalign Specifix Attachment System (include Engagement Features) lnvisalign Specifix Attachment System Invisalign System with Mandibular Advancement Enhanced Precision Wings Invisalign System - Express Invisalign System - Lite Invisalign Go Invisalign Touch-Up Invisalign Lite Invisalign Swift Invisalign Go Plus Invisalign System with Mandibular Advancement Precision Wings Invisalign Full Invisalign System - Comprehensive Invisalign Teen Invisalign First-Moderate Invisalign I7 Invisalign Express 10 Invisalign System - Moderate Invisalign System - Teen Package Invisalign System-Comprehensive Phase 2 Invisalign Assist Invisalign Express 5 Invisalign First-Comprehensive Invisalign System Orthodontic Appliance 3D Treatment Planning Software - ClinCheck Pro 6 3D Treatment Planning Software - ClinCheck Pro 6 Invisalign System with Mandibular Advancement featuring Occlusal Blocks Invisalign Lens Invisalign System with Integrated Button Invisalign Palatal Holder Invisalign Palatal Expander Invisalign Assist Invisalign Express 10 Invisalign Teen Realine Invisalign i7 Invisalign Lite Invisalign System Orthodontic Appliance Invisalign Go Invisible Aligner System Invisalign System - Comprehensive Invisalign System - Lite Invisalign First-Moderate Invisalign System - Moderate Invisalign System - Express Invisalign First-Comprehensive Invisalign Deluxe Smile Signature Smile Invisalign System-Comprehensive Phase 2 Invisalign Go Plus Invisalign Signature Plus Smile Invisalign Swift Invisalign Touch-Up Invisalign System - Teen Package Invisalign Full Invisalign Express 5 Invisalign Ultrasonic Cleaning Station Invisalign Cheek Retractor, Medium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2026-01-29
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2007-04-04
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-11-17
PNN	Orthodontic Software	Dental	Class 2	872.5470	2025-11-17
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2011-12-05
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2011-12-05
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2011-12-05
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-01-19
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2007-04-04
QJK	Intraoral Camera	Dental	Class 2	872.3661	2024-10-25
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2024-10-25
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2018-11-09
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2011-12-05
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2025-11-18
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-11-18
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2022-09-21
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-11-28
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2022-09-30
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-09-02
PNN	Orthodontic Software	Dental	Class 2	872.5470	2025-09-02
PNN	Orthodontic Software	Dental	Class 2	872.5470	2023-12-20
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-12-20
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2006-04-19
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-07-21
EIG	Retractor, All Types	Dental	Class 1	872.4565	2020-04-22

Official Correspondent

No official correspondent registered.

US Agent Details

Lifei Liu Business: Align Technology, Inc. Email: l_liu@aligntech.com Phone: (408) 4701000

Related Public Records

Same Entity

Align Technology, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007527669	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX
2953749	Align Technology, Inc.	San Jose, CA, US
3025237243	Align Technology AFAB Poland Sp. z o.o.	Wroclaw Dolnoslaskie, PL
3009646999	Align Technology, Ltd.	Petach Tikva Central, IL
3012138716	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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3008261720	JJGC Industria e Comercio de Materiais Dentarios SA	Curitiba Parana, BR
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005695824. Last updated year: 2026. Please use registration number 3005695824 when referencing this establishment in official correspondence.