All topics · intraoral-cooling-devices
topicintraoral-cooling-devices
Federal Register documents tagged intraoral-cooling-devices. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
- docs tracked
- 1
- M4+ recent
- 1
- agencies issuing
- 2
§ 01 Agencies issuing on this topic
§ 02 Recent documents
-
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
Action: Review intraoral cooling device submissions and labeling for compliance with FDA class II special controls.
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.
Monitor intraoral-cooling-devices in real time.
Subscribe to a feed that already watches this topic, or build a custom watchlist scoped exactly to your team's terms.