Align Technology, Inc.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (2)
- Light Transmission Caries DetectorProduct code NTK (opens in a new tab) · Class II · Dental · 21 CFR 872.1745
- Intraoral CameraProduct code QJK (opens in a new tab) · Class II · Dental · 21 CFR 872.3661
Recalls & enforcement
- Class IICompleted2022-12-053D 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.
Related
- All facilities operated by Align Technology, Inc.
- Aligntech de Mexico S, de R. L. de C. V. (MX)
- Align Technology de Costa Rica S.R.L (CR)
- Aligntech de Mexico S, de R. L. de C. V. (MX)
- Align Technology, Ltd. (IL)
- Align Technology AFAB Poland Sp. z o.o. (PL)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Align Technology, Inc. (FEI 3002519584) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002519584-align-technology-inc/
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