Align Technology AFAB Poland Sp. z o.o.

FDA Device Registration & Listing · Wroclaw Dolnoslaskie, PL · Registration 3025237243

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025237243
FEI Number
3025237243
Entity Name
Align Technology AFAB Poland Sp. z o.o.
City/State/Country
Wroclaw Dolnoslaskie, PL
Establishment Address
Bierutowska 44 Street, Wroclaw Dolnoslaskie 51-317, PL
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
K241412
PMA Number
N/A

All Registered Proprietary Names

Vivera Retainer Invisalign Retainer Vivera 3D retainer 3D Treatment Planning Software - ClinCheck Pro 6 Invisalign System - Comprehensive Phase 2 Invisalign Touch-Up Invisalign i7 Invisalign System - Lite Invisalign Go Invisalign Go Plus Invisalign First - Comprehensive Invisalign Full Invisalign Teen Invisalign Express 5 Invisalign System - Teen Package Invisalign Access Invisalign System - Comprehensive iGo Plus Invisalign Assist Invisalign Express 10 Invisalign Go Express Invisalign Lite iGo Invisalign System - Express Invisalign System - Moderate Invisalign ART

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2007-10-26
NXC Aligner, Sequential Dental Class 2 872.5470 2024-07-03
PNN Orthodontic Software Dental Class 2 872.5470 2024-07-03

Official Correspondent

No official correspondent registered.

US Agent Details

Lifei Liu 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
3009646999 Align Technology, Ltd. Petach Tikva Central, IL
3012138716 Aligntech de Mexico S, de R. L. de C. V. Cd. Juarez Chihuahua, MX
3005695824 Align Technology de Costa Rica S.R.L Belen Heredia, CR

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3019793783 Aceso Dental Laboratory Company Limited An Phuoc Ward Dong Nai, VN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025237243. Last updated year: 2026. Please use registration number 3025237243 when referencing this establishment in official correspondence.
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