Dental Devices; Reclassification of Electrical Salivary Stimulator System
other · Food and Drug Administration · Rule · Published 2015-11-20 · Effective 2015-12-21 · 80 FR 72585
Document
Document number
2015-29638
Federal Register citation
80 FR 72585
CFR reference
21 CFR 872
Type
Rule
Action
Final order.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-11-20
Effective date
2015-12-21
HHS docket
Docket No. FDA-2014-N-1243
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the "electrical salivary stimulator system." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.