Cleared Traditional

Slow Wave DS8 (SWDS802)

K240463 · Slow Wave, Inc. · Dental

Jun 2024

Decision

109d

Days

—

Risk

About This 510(k) Submission

K240463 is an FDA 510(k) clearance for the Slow Wave DS8 (SWDS802), a Mouthguard, Prescription, submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on June 4, 2024, 109 days after receiving the submission on February 16, 2024. This device falls under the Dental review panel.

Submission Details

510(k) Number	K240463 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2024
Decision Date	June 04, 2024
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF