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510(k) K073045

SAPPHIRE CERAMIC BRACKET by Ortho Technology, Inc. — Product Code NJM

K073045 is an FDA 510(k) premarket notification submitted by Ortho Technology, Inc. for the device "SAPPHIRE CERAMIC BRACKET". The FDA issued a decision of Substantially Equivalent on December 18, 2007. The device falls under product code NJM (Bracket, Ceramic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Ortho Technology, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2007
Date Received
October 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Ortho Technology, Inc.

  • K112707 — GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM (January 13, 2012)
  • K051751 — EQUA-PULL SAFETY RELEASE MODULE (July 22, 2005)
  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)

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