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510(k) K051552

O.A.S.I. SYSTEM by Lancer Orthodontics, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2005
Date Received
June 13, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Lancer Orthodontics, Inc.

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  • 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)
  • K902075 — INTRIGUE CERAMIC BRACKET (August 6, 1990)

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