510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191320Substantially Equivalent

Slow Wave DS8

Slow Wave, Inc., Spicewood TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191320 is the FDA 510(k) clearance record for Slow Wave DS8, a class II device, cleared for Slow Wave, Inc. on under FDA product code LQZ (Device, Jaw Repositioning). FDA records list 2 510(k) clearances for Slow Wave, Inc., from to . As of , FDA records show no recalls naming K191320.

Clearance record

Decision date
Received
(506 days to decision)
Product code
LQZ Device, Jaw Repositioning
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Slow Wave, Inc. 26100 Countryside Dr., Spicewood TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQZ

Trailing 12 months

FDA records hold no clearances under product code LQZ in the trailing twelve months.

FDA records show no clearances under product code LQZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260