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510(k) K922818

SNORE-NO-MORE by Great Lakes Orthodontics, Ltd. — Product Code LQZ

K922818 is an FDA 510(k) premarket notification submitted by Great Lakes Orthodontics, Ltd. for the device "SNORE-NO-MORE". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Great Lakes Orthodontics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
June 11, 1992
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

Other clearances by Great Lakes Orthodontics, Ltd.

  • K172765 — Smart Moves Complete (June 1, 2018)
  • K150702 — Exceed Tx (March 24, 2016)
  • K083479 — BIOCRYL X (February 27, 2009)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K040881 — METACRYL (May 25, 2004)
  • K033632 — VARIFLEX (January 21, 2004)
  • K925275 — SOFT DENTURE RELINE MATERIAL ELASTOLINE (January 11, 1993)
  • K870908 — STEADY RESIN (March 19, 1987)
  • K861424 — ADAPTABLE CLASS III MASK (May 29, 1986)
  • K840805 — ORAL SAFE (March 30, 1984)

Other clearances for product code LQZ

  • K233754 — AIO Breathe (February 23, 2024)
  • 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