FDA WARNING_LETTER - RESET TECHNOLOGY CORPORATION - December 20, 2024

On June 9, 2025, the FDA issued a Warning Letter to Reset Technology Corporation following an inspection from October 29 to December 20, 2024, at their Englewood Cliffs, NJ facility. The inspection revealed that the firm's ResetSmile Partial Denture Device and at-home ResetSmile Impression Kit Device are adulterated and misbranded.

Key violations include: 1. **Quality System Regulation (21 CFR Part 820) Deficiencies:** * Failure to validate manufacturing and cleaning processes (e.g., scanning, CAD design, 3D printing, post-printing QC, cleaning) as required by 21 CFR 820.75(a). * Inadequate procedures for controlling nonconforming product, lacking sufficient detail for documentation, evaluation, and disposition (21 CFR 820.90(a)). * Failure to establish rework procedures, including retesting, reevaluation, and documentation in the Device History Record (DHR) (21 CFR 820.90(b)(2)). * Inadequate investigation of complaints alleging device failures (21 CFR 820.198(c)). * Failure to adequately maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints, including MDR reportability (21 CFR 820.1