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510(k) K080906

CDB CLIP by Cdb Corporation — Product Code NJM

K080906 is an FDA 510(k) premarket notification submitted by Cdb Corporation for the device "CDB CLIP". The FDA issued a decision of Substantially Equivalent on October 17, 2008. The device falls under product code NJM (Bracket, Ceramic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Cdb Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2008
Date Received
April 1, 2008
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 Cdb Corporation

  • K212173 — HDH Treatment Planning System (January 25, 2022)
  • K210613 — HIT Clear Aligner (June 4, 2021)
  • K191823 — Clear-Aligners (December 20, 2019)
  • K160957 — CDB Self Ligating Bracket 8F (September 27, 2016)
  • K091702 — CDB FLIP-SIDE-CLIP BRACKET (August 7, 2009)

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