Invisalign Swift 9027
Invisalign Swift 9027 is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Align Technology Inc., cleared under FDA 510(k) K181739 on 26 Oct 2018 and listed in FDA GUDID since 20 Jan 2020 (UDI-DI 00816063020592), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816063020592 | Date20 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181739 | Date26 Oct 2018 | StatusActive |
Official records
- AccessGUDID record 00816063020592
- FDA 510(k) database K181739
Across registries
- FDA 510(k) K181739 decided 26 Oct 2018 Active
- FDA GUDID UDI-DI 00816063020592 listed 20 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K181739
- Listed FDA GUDID 00816063020592
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Invisalign Swift
- Generic name
- Orthodontic progressive aligner
- Model / reference
- 9027
- Primary DI / UDI-DI
- 00816063020592
- 510(k) Number
- FDA product code
- NXC
- GMDN term
- Orthodontic progressive aligner
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
- Argen Clear Aligner by The Argen Corporation
- ClearCorrect Aligner, Sequential by Clearcorrect, Inc.
- Smilers Aligner by BIOTECH DENTAL SMILERS
- UniSmile Clear Aligner System by VITANG TECHNOLOGY LLC
- Clear Image Aligner by Specialty Appliance Works, Inc.
- 3M Clear Tray Aligner by 3M UNITEK CORPORATION
- Nubrace Invisible Removable Orthodontics by Nubrace, Inc.
- CREOKORREKT Aligners by CREODENT PROSTHETICS LTD
- Vivid Aligners by Orthodent Laboratory, Inc.
- TP Orthodontics Clear Aligner System by TP ORTHODONTICS, INC.