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510(k) K090911

IST SNORING APPLIANCE by Dental Crafters — Product Code LQZ

K090911 is an FDA 510(k) premarket notification submitted by Dental Crafters for the device "IST SNORING APPLIANCE". The FDA issued a decision of Substantially Equivalent on September 11, 2009. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2009
Date Received
April 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Jaw Repositioning
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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  • K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea (July 12, 2023)
  • K203712 — The Slide (July 20, 2021)
  • K191320 — Slow Wave DS8 (October 2, 2020)
  • K192581 — The NightBlocks Appliance (January 28, 2020)
  • K162816 — SML-OSA2 Appliances (July 27, 2017)
  • K130130 — ATG/SM-OSA APPLIANCES (August 26, 2013)
  • K112627 — MILLENIUM ANTI-SNORING DEVICE (June 6, 2012)
  • K112766 — SNORKEL (June 4, 2012)
  • K113201 — NARVAL CC (December 1, 2011)

FDA data resources