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510(k) K902075

INTRIGUE CERAMIC BRACKET by Lancer Orthodontics, Inc. — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1990
Date Received
May 8, 1990
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 Lancer Orthodontics, Inc.

  • K122069 — STORM MINI SCREW (April 11, 2013)
  • K071192 — BLUGOO HD (June 22, 2007)
  • K051552 — O.A.S.I. SYSTEM (September 19, 2005)
  • K991481 — PARAGON (August 11, 1999)
  • K904090 — ORTHODONTIC BONDING ADHESIVE CONTROL (April 29, 1991)
  • K904092 — LANCER ORIGINAL, SIERRA, GENERAL PURPOSE (November 9, 1990)
  • K904093 — BUCCAL TUBE, BUCCAL ATTACHMENT (November 7, 1990)
  • K904091 — TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO (November 5, 1990)
  • K904094 — C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE (November 2, 1990)
  • K904089 — PERMA MESH (November 2, 1990)

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