Alert detail
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
What changed
Final Rule published 2026-06-01. The Food and Drug Administration (FDA) is classifying the intraoral cooling device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the intraoral cooling device. We are taking this action because we have determined that classifying the device into class II will provide a
Who’s affected: Multi-specialty billing teams · Effective: June 1, 2026
Primary source: View the official CMS/MAC document ↗
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