Cleared Traditional

K191320 - Slow Wave DS8 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K191320 is an FDA 510(k) clearance for the Slow Wave DS8. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on October 2, 2020 after a review of 506 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Slow Wave, Inc. devices

Submission Details

510(k) Number K191320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
379d slower than avg
Panel avg: 127d · This submission: 506d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQZ Device, Jaw Repositioning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.