Cleared Traditional

SILENTSLEEP (K801927) - FDA 510(k) Clearance

Class I Dental device.

K801927 · Slumber Research, Inc. · Dental device
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Nov 1980
Decision
94d
Days
Class 1
Risk

K801927 is an FDA 510(k) clearance for the SILENTSLEEP. Classified as Mouthpiece, Saliva Ejector (product code DYN), Class I - General Controls.

Submitted by Slumber Research, Inc. (Walker, US). The FDA issued a Cleared decision on November 14, 1980 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Slumber Research, Inc. devices

Submission Details

510(k) Number K801927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1980
Decision Date November 14, 1980
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DYN Mouthpiece, Saliva Ejector
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.