Home / 510(k) Clearances / K232011

510(k) K232011

Cleo by American Orthodontics — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2023
Date Received
July 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bracket, Ceramic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

Other clearances by American Orthodontics

  • K242537 — BracePaste Fluoride Sealant (August 27, 2024)
  • 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)
  • K922984 — ORTHODONTIC BITE (March 31, 1993)

Other clearances for product code NJM

  • K232827 — LightForce Orthodontic System (September 14, 2023)
  • K231635 — A-Line Advanced (June 6, 2023)
  • K230225 — DynaFlex Clear Brackets & Buttons (June 5, 2023)
  • K222847 — Ceramic Brackets Orthometric (May 4, 2023)
  • K222764 — LightForce Orthodontic System (September 14, 2022)
  • K220689 — Vatech Clismile (May 6, 2022)
  • K201410 — VENUS Bracket, ROSE Bracket (March 12, 2021)
  • K201038 — Luce Ceramic Bracket (October 9, 2020)
  • K200148 — LightForce Orthodontic System (LFO System) (February 21, 2020)
  • K182672 — ROSA Bracket (November 15, 2019)