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510(k) K203712

The Slide by Biotex, Inc. — Product Code LQZ

K203712 is an FDA 510(k) premarket notification submitted by Biotex, Inc. for the device "The Slide". The FDA issued a decision of Substantially Equivalent on July 20, 2021. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Biotex, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2021
Date Received
December 21, 2020
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 Biotex, Inc.

  • K233442 — troCarWash™ System (May 21, 2024)
  • K222695 — troCarWash™ System (February 17, 2023)
  • K161704 — Phasor Drill (December 1, 2016)
  • K092197 — PHOTEX30 DIODE LASER SERIES: 980, 810, 940 (October 6, 2009)
  • K081656 — VISUALASE THERMAL THERAPY SYSTEM (September 10, 2008)
  • K071328 — VISUALASE THERMAL THERAPY SYSTEM (August 31, 2007)
  • K063505 — VISUALASE ENVISION SOFTWARE SYSTEM (December 12, 2006)
  • K060304 — PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 (March 21, 2006)
  • K053087 — VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETE (March 1, 2006)

Other clearances for product code LQZ

  • K233754 — AIO Breathe (February 23, 2024)
  • K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea (July 12, 2023)
  • 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)
  • K090911 — IST SNORING APPLIANCE (September 11, 2009)

FDA data resources