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510(k) K180404

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System by 3M Healthcare — Product Code NJM

K180404 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System". The FDA issued a decision of Substantially Equivalent on March 16, 2018. The device falls under product code NJM (Bracket, Ceramic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. 3M Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
February 14, 2018
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 3M Healthcare

  • K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (March 13, 2020)
  • K191355 — 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Ma (September 11, 2019)
  • K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face S (July 31, 2018)
  • K171116 — 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/18 (August 10, 2017)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)
  • K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (July 26, 1998)
  • K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (May 15, 1998)
  • K974553 — 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (February 3, 1998)

Other clearances for product code NJM

  • K232827 — LightForce Orthodontic System (September 14, 2023)
  • K232011 — Cleo (July 7, 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)

FDA data resources