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510(k) K090933

BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS by Forestadent Bernhard Forster GmbH — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2009
Date Received
April 2, 2009
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 Forestadent Bernhard Forster GmbH

  • K110275 — ORTHO EASY PIN (June 3, 2011)
  • K925240 — FACEBOW (June 18, 1993)
  • K924971 — FORESTADENT BRACKETS (May 27, 1993)

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