Attachment Template 100012
Attachment Template 100012 is an orthodontic resin positioning tray (FDA Class I; FDA product code QJJ, Indirect Bonding Tray) made by Align Technology Inc., cleared under FDA 510(k) K220287 on 7 Apr 2022 (2 earlier submissions) and listed in FDA GUDID since 24 Jul 2023 (UDI-DI 00816063022169), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816063022169 | Date24 Jul 2023 | StatusListed |
| United States | FDA 510(k) | NumberK220287 | Date7 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 00816063022169
- FDA 510(k) database K220287
- FDA 510(k) database K181739
- FDA 510(k) database K981095
Across registries
- FDA 510(k) K220287 decided 7 Apr 2022 Active
- FDA GUDID UDI-DI 00816063022169 listed 24 Jul 2023 Listed
Recalls
-
- Completed Z-1017-2023
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
Timeline
- Cleared FDA 510(k) K981095
- Cleared FDA 510(k) K181739
- Cleared FDA 510(k) K220287
- Recall initiated FDA recalls Z-1017-2023
- Listed FDA GUDID 00816063022169
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Attachment Template
- Generic name
- Orthodontic resin positioning tray
- Model / reference
- 100012
- Primary DI / UDI-DI
- 00816063022169
- FDA product code
- QJJ
- GMDN term
- Orthodontic resin positioning tray
- Device class
- Class I
- Regulation number
- 872.5410
- GUDID distribution status
- In Commercial Distribution