Home / 510(k) Clearances / K922984

510(k) K922984

ORTHODONTIC BITE by American Orthodontics — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
June 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by American Orthodontics

  • K242537 — BracePaste Fluoride Sealant (August 27, 2024)
  • K232011 — Cleo (July 7, 2023)
  • K202276 — BracePaste Band and Build LC (August 14, 2020)
  • K181910 — BracePaste MTP Light Cure Primer (October 15, 2018)
  • K172953 — Acid Etchant (February 6, 2018)
  • K160782 — BracePaste Adhesive (October 14, 2016)
  • K143117 — Wire Sterilization Package with Indicators (October 29, 2015)
  • K122753 — EMPOWER CLEAR (December 14, 2012)
  • K080749 — RADIANCE (August 4, 2008)
  • K925012 — PLASTIC CHAIN (September 13, 1993)

Other clearances for product code LRK

  • K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (March 3, 2026)
  • K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (March 2, 2026)
  • K252976 — Park Dental Nylon MAD (December 18, 2025)
  • K253868 — QuietLab Pro (December 5, 2025)
  • K252161 — Hushd Avera (November 25, 2025)
  • K252525 — AIO Breathe (November 6, 2025)
  • K252698 — NightGuard Aire Max (November 3, 2025)
  • K253355 — Difiney Advanced Anti Snoring Device 4.0 (October 29, 2025)
  • K251784 — Hushd Pro Z-Link (October 24, 2025)
  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)