Cleared Traditional

K240463 - Slow Wave DS8 (SWDS802)

K240463 · Slow Wave, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
109d
Days
-
Risk

K240463 is an FDA 510(k) clearance for the Slow Wave DS8 (SWDS802). Classified as Mouthguard, Prescription (product code MQC).

Submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on June 4, 2024 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 Slow Wave, Inc. devices

FDA 510(k) Submission Details - K240463

510(k) Number K240463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
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