Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
Review intraoral cooling device submissions and labeling for compliance with FDA class II special controls.
- Effective: June 1, 2026 — Rule effective on publication date.
§ 01 Summary
FDA classifies intraoral cooling devices as class II dental devices subject to special controls. The rule creates a codified regulatory classification for this device type, establishing the controls manufacturers must satisfy to provide reasonable assurance of safety and effectiveness.
§ 02 Why this matters
The rule places intraoral cooling devices into class II and makes identified special controls part of the codified classification, creating binding design, testing, labeling, or other control requirements for manufacturers marketing this device type.
§ 03 Topics
§ 04 Affected entities
- agency: FDA
- agency: HHS
- industry: dental-device-manufacturers
- statute: FDCA
§ 05 Matching feeds
§ 06 Source document
Read the full Federal Register entry on federalregister.gov.
Show classifier input (what GPT-5.5 saw)
Type: Rule Agencies: Health and Human Services Department; Food and Drug Administration Citation: 91 FR 32343 Title: Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device Abstract: 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 reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Classified Jun 3, 2026 by gpt-5.5. Fetched Jun 2, 2026.
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