FDA Registration
Active
🇵🇱 Poland
Align Technology AFAB Poland Sp. z o.o.
Reg #: 3025237243
·
FEI: 3025237243
·
Expires 2026
Products
4
Proprietary Names
27
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Align Technology AFAB Poland Sp. z o.o.
- Registration Number
- 3025237243
- FEI Number
- 3025237243
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bierutowska 44 Street
- City
- Wroclaw Dolnoslaskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K241412
Owner / Operator
- Firm Name
- Align Technology, Inc.
- Operator Number
- 9035576
- Address
- 410 North Scottsdale Road, Suite 1300
- City
- Tempe
- State
- AZ
- Postal Code
- 85281
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2007-10-26 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2024-07-03 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2024-07-03 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2026-01-29 |
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
Attachment Template
Establishment Types
Manufacture Medical Device