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510(k) K091035

FULL BREATH SLEEP APPLIANCE LOWER (FBSL) by Bryan Keropian Dds — Product Code LQZ

K091035 is an FDA 510(k) premarket notification submitted by Bryan Keropian Dds for the device "FULL BREATH SLEEP APPLIANCE LOWER (FBSL)". The FDA issued a decision of Substantially Equivalent on June 24, 2009. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Bryan Keropian Dds has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2009
Date Received
April 10, 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

Other clearances by Bryan Keropian Dds

  • K061228 — FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR (May 26, 2006)
  • K053065 — FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BU (January 3, 2006)
  • K052862 — FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) (December 30, 2005)

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