Cleared Traditional

Slow Wave DS8

K191320 · Slow Wave, Inc. · Dental
Oct 2020
Decision
506d
Days
Class 2
Risk

About This 510(k) Submission

K191320 is an FDA 510(k) clearance for the Slow Wave DS8, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on October 2, 2020, 506 days after receiving the submission on May 15, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K191320 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2019
Decision Date October 02, 2020
Days to Decision 506 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQZ — Device, Jaw Repositioning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570